What to Ask in Order to Define the User Needs for a Medical Device?

Defining your user needs is crucial to get on the right track before diving into design and development of your medical device. So...

What are the questions you can use to help define the user needs?
  1. What is the clinical job to be done your device is going to solve?
  2. What do you want the device to do in the customer?
  3. Which is the user persona for the device? Remember to consider all persons who could be an “enduser” and their level of ability or savvy with the device.
  4. When the customer is going to use the device? What are the activities the customer will be doing around that time? Will it be under certain circumstances, or all of the time?
  5. Under what context will the device be used?
  6. What types of procedures will the device be used for?
  7. Can the user interact directly with the device or needs help/support?
  8. Will the device chargeable or disposable?
  9. How are your features of your device different from what is already in the market?
  10. Other devices or products that will interact with the device?

Of course, the more questions you add, the better. At least, you should cover these 10 questions in order to have a better idea of the needs of your user regarding their medical device.

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Design Thinking is not Only for Products but Also for Sales

Design Thinking is not Only for Products but Also for Sales

Over the past few years, design thinking has quickly gained momentum in the business world. Some of the world’s leading brands have embraced design thinking as a means of optimizing product innovation. At its core, design thinking is a methodology for creative problem-solving. In stark contrast to analytical thinking, which involves breaking down ideas, design thinking involves building up ideas.

While design thinking has firmly implanted itself across product development teams, it has not secured a stronghold across sales teams — yet. Characterized by routinized activities, traditional sales methodologies tend to be at odds with the iterative methodology underpinning design thinking.

Times are changing. The sales cycle is becoming increasingly complex, and customers are demanding a more personalized experience. If you’re a sales rep, you know you need to up your game and become more innovative. Sales teams are recognizing the value of incorporating a design thinking approach into their daily activities. Salesforce’s sales team, for example, has embraced design thinking in its sales discovery process and has realized a 100% increase in revenue growth as a result. It’s time sales teams more broadly recognize the value of design thinking.

1. Empathize

Empathy is at the core of design thinking. Empathy involves both a cognitive dimension — an ability to look at a situation from another person’s perspective — and an affective dimension — an ability to relate to a person and develop an emotional bond with them.

The importance of empathy in sales cannot be overstated. Empathy is a key predictor of sales success. A groundbreaking study published in The Journal of Marketing Theory and Practice found a strong positive relationship between empathy and a buyer’s level of trust and his/her level of satisfaction. In our current sales landscape where a mere 3% of buyers trust reps — the only professions with less credibility include car sales, politics, and lobbying — seller trust is in short supply and high demand.

Empathy is especially valuable in the sales process because it encourages information sharing. Research has found that, according to buyers, the number one way for salespeople to create a positive sales experience is to listen to their needs. When we’re armed with so much information and data and a slew of AI and machine learning solutions, it’s easy to assume we know everything about the buyer. It’s important to first step inside your customers' shoes and listen to what really matters to them and what is top-of-mind.

2. Define

The defining stage's objective is to craft a problem statement or, in design thinking speak, a point of view. So often, salespeople define the problem before developing an empathetic understanding of a buyer’s needs. The result is solution selling. Solution selling has long past its expiration date. At least 50% of sales reps’ prospects are not good fits for their offering. Only by defining the buyer’s problem can salespeople determine whether there is a lucrative fit.

The define stage involves asking a lot of questions. Perhaps contrary to popular belief, this focus on questioning does not impair sales conversation but enhances it. According to one analysis of 519,000 discovery calls, there’s a clear relationship between the number of questions a sales rep asks a buyer and his/her likelihood of success.

3. Ideate

The ideate stage unlocks the true potential of design thinking, especially in the context of sales. This is when the focus shifts from problem identification to solution generation. And it’s all about quantity — about generating a wide range of possible solutions, not necessarily the final solution. It involves thinking beyond the obvious and necessarily entails significant creativity. How can I craft an offering that is uniquely suited to my buyer?

While often pushed under the carpet in sales, creativity is essential to sales and a key predictor of success. Research from the Aston Business School, a highly-regarded business school in Europe, revealed that sales professionals who were more creative generated higher sales than their less creative counterparts. Another study by Adobe found that companies that foster creativity are 3.5 times more likely to outperform their peers in revenue growth.

When crafting solutions to customers’ problems, sales reps must dig deep for their creative juices. How can you craft a sales pitch that strikes a strong emotional chord with the customer? Which decision-makers, in and beyond the C-Suite, should you involve? If the customer sells a free or inexpensive product or service, take it for a test run. Read through customer community forums and reviews. Don’t let up in terms of stepping inside the shoes of your customer. Only by embracing these types of activities can ideation be optimized.

4. Prototype

The fourth stage of the design thinking process is prototyping — developing more fleshed-out and scaled solutions. Prototyping shouldn’t be done in a black box — otherwise, you are sure to lose momentum. Prototyping is an opportunity to have a more directed conversation with your customer after the discovery calls. The most effective sales reps will involve champions and other affiliates from the customer’s organization in the prototyping process and vet ideas. Involving tangential stakeholders in the solution process goes a long way in making them feel valued and invested in the final solution.

5. Test

The final stage of the design thinking process is to test the final offering. This necessarily involves unveiling the fully fleshed-out pitch to all key stakeholders. During the test phase, salespeople need to be strategic and see themselves on the same team as the customer. They should use collaborative words and phrases — words like “we” and “together.” The “you versus us” mentality is dangerous.

Forrester predicts that one million US B2B sales reps will be out of a job by 2020. Salespeople can no longer afford to rely on so-called tried and true approaches. Nearly six in ten salespeople say that they don't change it when figuring out what works for them. In a world where each customer yearns personalized selling wants, this mindset is problematic. Design thinking — which is especially well suited for solving ambiguously defined problems — is key to establishing a genuine connection with customers and engaging them throughout the sales process. It’s key to sales success.

Understanding the Basics of Design Thinking

Understanding the Basics of Design Thinking

In his book The Sciences of the Artificial, Herbert Simon started what we now refer to as design thinking. Since then, numerous other works have been published detailing design thinking concepts and how it relates to all manner of different business models. One of the most famous icons to design thinking in the modern era is probably Apple, Inc. Let’s ask ourselves:

· Did you feel you needed an iPod before Apple created?

· Did you feel you needed an iPhone before Apple created it?

Apple’s genius during the early 2000s was not in creating new products that no one had ever heard of. There were dozens of cell phone manufacturers making quality cell phones before the iPhone landed. There were dozens of MP3 players on the market before the original iPod.

But, once Apple entered the arena, none of that mattered. Why? Because Apple understood the unarticulated needs (and in fact, you could even argue that Apple’s real genius was creating a need for a product by releasing that product!) of its customers. How were they able to do this?

How can we solve a problem for our customer in such a way that they don’t even know the problem exists until we show the solution?
The Five Phases of Design Thinking

Design thinking is a process of five distinct phases of execution. Those phases are:

· Empathize

· Define

· Ideate

· Prototype

· Test

Looking at that list, it seems to be a mix of skills from various disciplines. “Prototype” and “test” seem to be drawn from engineering and product development, whereas “empathize” and “ideate” come from a more psychological, social methodology.

Phase 1 — Empathize

Empathizing immediately sets design thinking apart from most of the other business models out there. True, most business models strive to understand their ideal client’s needs and wants, but few do it from a relational perspective. This is what Simon Sinek talks about in his book Start With Why: That people don’t buy what you do, they buy why you do it. For Apple, that meant understanding the desire of their customers to be a part of something. They weren’t buying things because it was the best. They were buying it because of the reasons behind WHY Apple made it. When the corporate world was turning its back on customer relations and focused more on profits than on value, Apple communicated a different mission and mindset, which allowed their sales to skyrocket.

Phase 2 — Define (The Problem)

Another crucial part of design thinking. The problem. The majority of creators will fail at this part because they think about problems as nouns. Problems are verbs. If you see a little girl trying to get cookies from the shelf, people will start listing the problems as:

· She needs a cookie

· She needs an adult

· She needs a ladder

· Maybe she needs milk with those cookies

While the truth is, she needs to reach. Reaching is the problem, not the cookies. If you solve the reaching problem, you solve anything she will want to reach in the future. Once we understand others' unarticulated needs through authentically empathizing, it’s time to define the problem.

Phase 3 — Ideate

Ideation, the process of coming up with potential solutions to your customers’ unarticulated needs, can only occur after those needs have been identified through empathy and the problem defined. Do we solve the problem through a product, or a relationship, or a service? Is it through expanding our business model to include other forms of retail or consumer service? As an operations manager, the unarticulated needs that I wasn’t meeting for my fellow workers were found in the way I was focused on problems, not on them personally. I felt like, and if nothing was going wrong, there was nothing for me to do. What was going on underneath the surface, and what I was failing to do, was to spend time with them, to learn their processes to the point that I could spot potential problems before they actually became problems. Again, this human-centered approach must consider, above all else, the user's experience, whether customer, employee, or client.

Phase 4 — Prototype

Prototyping doesn’t necessarily have to involve models or scaled-down products. Prototyping also applies to non-physical solutions as well, in terms of how we construct frameworks to solve problems. Obviously, there are times when physical prototyping is important, but the overarching goal of prototyping is to apply solutions in a controlled environment to allow for testing, the fifth phase.

Phase 5 — Test

The final and simplest phase of design thinking. Since design thinking doesn’t flow like time in a strictly linear fashion between stages, there are times when prototyping leads back to ideation and when defining the problem actually requires more time spent empathizing to reassess the customer’s needs. Because of this frequently recursive nature, by the time we arrive at the design thinking process's final phase, sometimes testing merely confirms the last step in our solution. Other times, it can restart the entire process from the beginning. The importance of moving fluidly throughout all five phases.


Creativity is about doing, not thinking. Design thinking as well is about playing and acting. Those actions will swing between a process-oriented approach and a human-oriented approach depending on the project. At the end of it all, whether we are talking about coworkers or customers, the one thing they all have in common is that they are people looking for solutions to their problems. Solving the problem without addressing the people will only lead to frustration and failure. Providing a solutions-based approach to problems rather than a problems-based approach to problems will guarantee a greater chance of lasting implementation and effectiveness of whatever problem we’re solving.


· https://www.ideou.com/pages/design-thinking

· https://www.creativityatwork.com/design-thinking-strategy-for-innovation/

· https://dschool.stanford.edu/resources-collections/a-virtual-crash-course-in-design-thinking

· https://www.interaction-design.org/literature/article/5-stages-in-the-design-thinking-process

· https://hbr.org/2008/06/design-thinking

CAPA Process Explained in Simple Steps

CAPA Process Explained in Simple Steps

Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations.

The key thing about the CAPA process is that there are a lot of different processes that feed into it. You need to be diligent, but also apply scrutiny to what does and doesn’t require CAPA. Remember, it should be reserved for those systemic issues - every issue is not a CAPA!

Once you have something that’s worthy of a CAPA, here are the steps:

FDA Pathways to Make your Medical Device

FDA Pathways to Make your Medical Device

If you are in the medical device industry in the U.S is likely that you heard of the 510(k) process. Those working on high-risk devices may be familiar with the PMA and De Novo pathways. These are the three options that are most commonly used by device companies.

However, there are seven major pathways that can be used to bring a medical device to market

So many people assume the 510(k) route is right for them because it is what everyone else does. Not always the case, and one of the other pathways might actually be better for your company.

Don’t look at the regulatory process as a series of hoops to jump through. Instead, focus on creating a regulatory strategy for your specific device that sets you apart from your competition.

The 7 major pathways to market in the U.S. include:

  1. Custom Device Exemption (CDE)
  2. Expanded Access Program (EAP)
  3. Product Development Protocol (PDP)
  4. Premarket Notification 510(k)
  5. Premarket Approval (PMA)
  6. De Novo
  7. Humanitarian Device Exemption (HDE)

Custom Device Exemption (CDE)

Are you developing a custom device for a specific patient? If so, your device falls under the Custom Device Exemption (CDE) pathway.

The product should be specifically designed to treat a unique pathology or physiological condition that no other device is domestically available to treat. It must be assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of the patient.

The device must be created or modified in order to comply with the order of an individual physician or dentist, typically in the form of a prescription. Not only must the clinician order the device, but it must also be used in the normal course of the professional practice of that physician or dentist.

The FDA even states that companies are limited to no more than 5 units per year of a particular device type.

CDE devices are exempt from PMA or 510(k) submission process but the company still needs to comply with the following regulations:

  • Design Controls (21 CFR Part 820).
  • Medical Device Reporting (21 CFR Part 803).
  • Labeling (21 CFR Part 801).
  • Corrections and Removals (21 CFR Part 806).
  • Registration and Listing (21 CFR Part 807).

Expanded Access Program (EAP)

The Expanded Access program, often referred to as the compassionate use or emergency use provision. It allows an investigational device to be used, outside of a clinical trial, in situations where a seriously ill patient has few if any alternatives.

Although there are often ethical considerations, it may be appropriate to evaluate this option as a way to get early feasibility data for high-risk devices, especially when suitable animal models are unavailable. Like the HDE, this data could then be used to expand the label in the future.

Expanded access may be an appropriate pathway for you to choose when all the following apply:

  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
  • The patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential patient benefit justifies the potential risks of treatment.

Product Development Protocol

The Product Development Protocol (PDP) is a subset of the PMA process that allows for another pathway for companies with devices in which the technology is well established in the industry.

This pathway allows the company to come to an early agreement with the FDA about how the safety and effectiveness of the device will be shown. The two parties are essentially creating a contract that describes design and development activities, including the outputs of these activities, and acceptance criteria for these outputs.

The company can follow the plan on their own time and report back to the FDA on the agreed-upon milestones. At the end of the process, the company is considered to have “completed” a PDP, which gives them an “approved” PMA.

Premarket Notification 510(K)

The Premarket Notification 510(k) pathway is the most common route taken when launching a medical device. Almost all Class II devices and certain Class I devices will require a 510(k).

The purpose of a 510(k) submission is to provide the FDA with documented evidence showing that your medical device is substantially equivalent in terms of safety and effectiveness to a predicate device.

A predicate device is one that is already legally marketed and shares the same intended use and technological characteristics as your device. You are required to compare and contrast your device with the predicate by summarizing information from your design controls process, such as design features and verification testing.

The FDA typically processes 510(k) applications in 30–90 days. Depending on the robustness of your initial application, there may be a period of back and forth discussions, which can delay the process. It is important to plan ahead and provide all appropriate documentation at the time of initial submission.

Premarket Approval (PMA)

Class III devices, and any device that cannot provide substantial equivalence to a Class I or Class II device through the 510(k) process, must use the Premarket Approval (PMA) pathway.

The PMA process is the most involved as scientific evidence, typically in the form of a clinical trial, is needed to prove the safety and effectiveness of your device.

The FDA will either approve or reject the application within 180 days. The different steps of the review process include:

  1. FDA staff will determine completeness through an administrative and limited scientific review.
  2. FDA staff will conduct an in-depth scientific, regulatory, and Quality System review.
  3. An advisory committee will review and offer any recommendations.
  4. Any final deliberations will occur and the FDA will document and notify you of their final decision.

De Novo

If you are developing a lower risk, “novel” device, and struggling to find a predicate, the De Novo pathway might be the best option for you.

The De Novo pathway has actually been around since 1997 but many people do not know about it since it is not very commonly used. Companies that do not qualify for 510(k) clearance, due to the fact that they cannot provide substantial equivalence to a device on the market, should learn more about the De Novo pathway.

Since comparison to a predicate is not needed, companies have a “blank canvas” when it comes to labeling and can set a standard that may give them a competitive advantage over others. One of the key things to remember about the De Novo pathway is you must show your device presents low to moderate risk through a robust risk mitigation strategy.

Humanitarian Device Exemption (HDE)

The Humanitarian Device Exemption (HDE) pathway is for devices that are intended to treat or diagnose conditions or diseases that affect small or rare populations.

This pathway involves a two-step process. The FDA must grant a Humanitarian Use Device (HUD) exemption and the device company must then submit an HDE application to the appropriate review center.

Another important requirement is that there cannot be another comparable device on the market that shares the same intended use. The FDA will consider the following when determining if there are comparable devices on the market:

  • The device’s indications for use and technological characteristics.
  • The patient population to be treated or diagnosed with the device.
  • Whether the device meets the needs of the identified patient population.

Part of the rationale for providing this pathway is there may not be a large enough patient population with clinical data to satisfy regular FDA requirements of safety and efficacy. Since these devices may be very crucial to patients with rare conditions, the FDA put it in place to do a proper review to determine if the device can be sold.

What are the Design Inputs?

What are the Design Inputs?

Here is the official FDA regulation for design controls pertaining to design inputs, as found in Part 820.30(c):

Each manufacturer shall establish and maintain procedures to ensure that design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

ISO 13485:2016 also covers this topic in section 7.3.3 Design and Development Inputs:

Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:

a) functional, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management

These inputs shall be reviewed and approved.

Requirements shall be complete, unambiguous, and not in conflict with each other.

There are several terms used interchangeably when referring to design inputs:

  • Design inputs
  • Design requirements
  • Design input requirements
  • Design and development requirements
  • Product requirements

Medical device product development should be a holistic process that builds upon itself as the project progresses.

Rushing the product to the market isn’t a recommended best practice in medical device development. Spending time in design inputs will really benefit your project. In device development, establishing design inputs can easily take up to 20% of the entire project timeline.

Writing design inputs takes practice and dedication. Also, design inputs should not just be the responsibility of one person. It’s a team effort. When a team is involved, you get the benefit of everyone’s opinions and experience.

You also should consider all sorts of other sources to help you define design inputs:

  • Industry standards
  • Regulations
  • Previous projects/products
  • Competitor products
  • End-users
  • Prototypes

It’s important to remember that user needs should be established first in order to inform design inputs. Your goals when defining design inputs include:

  • Capturing all functional, performance, safety, and regulatory requirements.
  • Build upon user needs and intended use.
  • Make sure design inputs are clear and objective.
  • State design inputs in a way that allows you to prove/disprove them.

You have to consider all types of sources and resources for design inputs. Your design inputs need to be comprehensive, covering all aspects of your medical device.

What to Ask in Order to Define the User Needs for a Medical Device?

What to Ask in Order to Define the User Needs for a Medical Device?

Defining your user needs is crucial to get on the right track before diving into design and development of your medical device. So...

What are the questions you can use to help define the user needs?
  1. What is the clinical job to be done your device is going to solve?
  2. What do you want the device to do in the customer?
  3. Which is the user persona for the device? Remember to consider all persons who could be an “enduser” and their level of ability or savvy with the device.
  4. When the customer is going to use the device? What are the activities the customer will be doing around that time? Will it be under certain circumstances, or all of the time?
  5. Under what context will the device be used?
  6. What types of procedures will the device be used for?
  7. Can the user interact directly with the device or needs help/support?
  8. Will the device chargeable or disposable?
  9. How are your features of your device different from what is already in the market?
  10. Other devices or products that will interact with the device?

Of course, the more questions you add, the better. At least, you should cover these 10 questions in order to have a better idea of the needs of your user regarding their medical device.

The Top 100 Medical Device Acronyms you Should Know

The Top 100 Medical Device Acronyms you Should Know

In collaboration with the work of Jon Speer in July 19, 2020

Every industry in the world uses acronyms, and the overlap between multiple fields can be a source of confusion for professionals. There’s no room for confusion in the medical device industry, as a miscommunication could potentially lead to a product defect or adverse event with serious consequences.

Here the list:

21 CFR PART 11

Part 11 of Title 21 in the Code of Federal Regulations, commonly referred to as 21 CFR Part 11 or Part 11 for shorthand, establishes the acceptance criteria by FDA of electronic records, electronic signatures and handwritten signatures executed to electronic documents.

Compliance of quality systems with 21 CFR Part 11 requirements applies to the medical device industry, in addition to pharmaceutical, biotechnology, and other FDA-regulated industries.

21 CFR PART 820

FDA maintains quality system regulations, or QSR, found in 21 CFR Part 820, which establishes the quality system requirements for all medical device manufacturers in the United States. Manufacturers are required to establish and maintain a quality system that is appropriate for the medical device to ensure both the safety and efficacy for its intended use, per the requirements of 21 CFR Part 820.


A 483 observation, or “inspectional observation,” is a notice issued by an FDA inspector to flag potential regulatory violations found during a routine inspection. A Form 483 observation may be issued regarding any violation under FDA jurisdiction. Failure to demonstrate handling of the observed problems can be escalated to a warning letter.


A 510(k) is a regulatory premarket submission made to FDA for a Class I, II, or III medical device that doesn’t otherwise require premarket approval. The purpose of a 510(k) submission must demonstrate a safe and effective device that is substantial equivalent to an existing legally marketed device.


Application Lifecycle Management, or ALM, involves the specification, design, development and testing of software tools. ALM systems are used to manage quality and demonstrate compliance during the software delivery process.


An Auditing Organization, or AO, is responsible for auditing medical device manufacturers to evaluate conformity with quality management system requirements and other medical device regulatory requirements. An AO may be an independent organization or a Regulatory Authority (RA).

AOs participating in the Medical Device Single Audit Program (MDSAP) may conduct a single regulatory audit of a manufacturer which satisfies the relevant requirements of RAs participating in MDSAP.


An Approved Supplier List, or ASL, is an internal list kept by medical device manufacturers to record suppliers known to meet the quality and performance standards of the manufacturing organization.


A Bill of Materials, or BOM, is a complete list of raw materials, assemblies, and subassemblies required to produce a device, as well as the quantities required for each. A BOM is required to carry out change management processes for a medical device.


A Competent Authority, or CA, is a body within the government of a Member State in the European Union. A CA transposes the requirements of Europe's medical device regulation (MDR) into the national law of each Member State. For example, the Federal Institute for Drugs and Medical Devices (BfArM) is the the CA for Germany.


A Conformity Assessment, or CA, is carried out by an EU Notified Body to determine that a medical device is safe and performs as intended by the manufacturer. Medical devices must pass a conformity assessment in order to obtain CE Marking.


Computer-Aided Design (CAD) software allows device manufacturers and designers to draft detailed designs, including precise specifications and measurements. CAD software files can be stored on a digital database for reference.


Corrective and Preventive Action, or CAPA, is a quality system process carried out by a medical device organization to reduce and/or eliminate potential sources of risk and regulatory non-conformance or noncompliance.


A CE Marking, or CE Mark, certification must be obtained by medical device manufacturers for product distribution into the European Union (EU) marketplace. CE Marks are issued by third-party organizations, known as a Notified Bodies, and indicate compliance with the applicable EU medical device regulations (MDR).


The European Committee for Standardization, or CEN, is a public standards organization that develops standards for medical devices for sale in the European Union (EU). CEN can be compared to the Food and Drug Administration (FDA), which maintains and enforces medical device regulations in the U.S. marketplace.


The Center for Devices and Radiological Health, or CDRH, is a branch of the U.S. Food and Drug Administration (FDA) responsible for overseeing the approval of medical devices for sale in the U.S. market and also monitors the manufacturing, performance, and safety of those medical devices.


A Clinical Evaluation Report, or CER, provides clinical evidence that a medical device will perform as expected, such that no safety issues occur while using it. European regulations require medical device manufacturers to perform a conformity assessment, of which include CER documentation, in order to legally market a product in the EU.


Cost of Quality, or CoQ, is a system for measuring the financial impact that a quality system and its processes has on a business. Medical device companies can use CoQ to calculate potential savings and weigh those against the costs associated with internal process improvements.


Computer System Validation, or CSV, is a process used to demonstrate that computer systems, including hardware and software, used in medical device manufacture meet the regulations outlined in 21 CFR Part 11.


Current Good Manufacturing Practices, or cGMP, are minimum standards provided by FDA for manufacturing processes and facilities. The FDA cGMP standards establish a framework for medical device manufacturers to follow and allow for greater flexibility in achieving various quality requirements.


A Document Change Order, or DCO, is a formalized process in medical device change management. The DCO process involves change requests to be made within an organization to a document or system in a standardized, traceable manner.


The De Novo regulatory pathway is a classification process that uses a risk-based methodology for novel medical device to be granted market entry for sale in the U.S. For a de novo submission to be granted by FDA, general controls must indicate that the device is safe and effective for its intended use.


The Deming Cycle is a methodology for monitoring quality efficacy and serves as a basis for traditional quality assurance. The Deming Cycle model is comprised of four parts: plan, do, study, and act. These parts are often summarized as PDSA.


Design Controls or DC, as defined by FDA in 21 CFR 820.30, are a systematic process that ensures specific design requirements are met by documented procedures that control the design of the medical device. The purpose of DCs is to demonstrate that a medical device is safe, effective, and performs as expected.


A Design Dossier, or DD, includes all contents of the technical file (TF), which describe a device’s design, manufacturing, and performance, as well as the documentation that demonstrates conformity with applicable regulatory requirements.


A Design of Experiment, or DoE, is a method for medical device manufacturers and engineers to validate internal processes and predict process variability in order to improve and maintain product quality.


A Design for Manufacture, or DFM, is a process for optimizing the design of a medical device for manufacturing. A DFM takes into account the cost of manufacture, as well as regulatory compliance and product performance.


A Design History File, or DHF, contains all documentation related to the design and development of a medical device. Medical device manufacturers in the U.S. market are required by law under FDA 21 CFR Part 820 to maintain a DHF.


The Device History Record, or DHR, acts as a record of production for a medical device and demonstrates it was manufactured according to information stored in the device master record (DMR). Manufacturers operating in the U.S. are required under CFR Part 820.184 to maintain a DHR, which contains information such as acceptance records for units or batches of products, unique product identifiers, and product counts.


A Device Master Record, or DMR, is a record of all the information and specifications required to produce a medical device. The DMR contains instructions for manufacturing, drawings and specifications for devices, and requirements for labeling and packaging. Manufacturers are required by FDA to maintain a DMR under CFR Part 820.181.


A Document Management System, or DMS, is a tool used to store and manage documents related to medical device development, as well as track any changes made to documents throughout the product lifecycle on an ongoing basis. A DMS is not synonymous with a Quality Management System, or QMS, which stores documents but also has a regulatory compliance focus.


An Engineering Change Order, or ECO, is a process that is triggered when an issue is raised with a medical device in terms of performance, cost-effectiveness, or the process of manufacturing the device. An ECO is typically followed by an analysis to determine whether action should be taken. Depending on the nature of the change, an ECO may lead to a CAPA investigation.


An Establishment Inspection Report, or EIR, is made by FDA in the event a Form 483 is issued following an inspection. The next steps after receiving an official EIR from FDA will be determined by the severity of the issues observed, as well as the 483 response. If significant deficiencies are observed, FDA may decide to issue a warning letter.


Enterprise Resource Planning, or ERP, refers to the management of business processes within the organization of a medical device organization. This is often carried out with the use of ERP tools that gather and organize business data and automate processes related to human resources and business practices.


The European Commission's new IVDR 2017/746, which is shorthand for In Vitro Diagnostic Regulation, is Europe's new regulation for in vitro diagnostic devices that is scheduled to go into effect 26 May 2022. The IVDR requires all existing IVD devices being sold in the EU market to undergo recertification for compliance with the new requirements, which supersede the previously held directives for in-vitro diagnostic devices (IVDD).


MDD is the Medical Device Directive for medical devices sold in the European marketplace, which was replaced in 2017 by the medical device regulation (MDR. The purpose of the directive was to harmonize laws and standards around medical devices marketed in the European Union.


EU MDR is a common abbreviation for the medical device Regulation (EU) 2017/745, which mandates the quality and safety requirements for medical devices produced and marketed in the European Union (EU). The EU medical device regulation supersedes the previously held medical device directives (MDD) that were in place up until 2017 and places strong emphasis on a total product lifecycle approach.


The European Database on Medical Devices, or EUDAMED, is a database developed by the European Commission to facilitate compliance with European medical device regulations. It's intended to function as a multipurpose system for registration, collaboration, and communication for multiple stakeholders in the medical device industry.


The Food and Drug Administration, or FDA, is a federal agency of the U.S. Department of Health and Human Services. The FDA is responsible for approving medical devices for manufacture and distribution within the U.S. Medical device manufacturers operating within the U.S. market are subject to FDA inspections and compliance with the requirements outlined in Title 21 of the Code of Regulations.


Failure Modes and Effects Analysis, or FMEA, is a method used to identify failures in a design or process associated with a medical device. FMEA is distinct from ISO 14971, the international standard for medical device risk management. The FMEA method can be broken into two parts: PFMEA for processes, and DFMEA for designs.


Fault Tree Analysis, or FTA, is an analytical method aimed at identifying points of failure and risk within a quality system. In medical device manufacture, FTA can be applied throughout the course of risk management activities to identify possible sources of risk.


Freedom to Operate, or FTO, refers to product infringement on intellectual property. Device manufacturers typically declare whether they have FTO in each market in which they plan to sell a new product.


Medical device manufacturers are required to comply with the General Safety and Performance Requirements (GSPRs) of the new EU MDR. The regulation splits GSPRs into three chapters, general requirements, requirements regarding design and manufacture, and requirements regarding the information supplied with the device.


Hazard Identification, or HID, is a risk management process in which device manufacturers determine whether situations, processes, or items associated with the production of their device may have the potential to cause harm.


An Investigational Device Exemption, or IDE, is an FDA exemption that allows an investigational device to be used for testing a device against premarket approval standards. An investigational device can be used to gather data on the safety and effectiveness of the device, and this data is submitted as an IDE for review by FDA.

IEC 60601

IEC 60601 is a standard pertaining to electrical medical equipment. Any medical device containing electronics must pass the necessary requirements outlined in IEC 60601.

Programmable Electrical Medical Systems, or PEMS, is a key part of what's covered in IEC 60601. PEMS consists of software, firmware, and equipment that can be programmed to carry out functions that aid medical care or treatment. The standard also covers mechanical safety, labeling, and risk management.

IEC 62304

IEC 62304 is a software framework that outlines software engineering and documentation practices. It is also recognized by FDA and provides a risk-based framework that can be used throughout entire medical device software lifecycle.


Instructions for Use, or IFU, are instructional materials used to convey relevant information to the end user. These materials must take into account the capabilities and limitations of the end user in order to communicate instructions as concisely and objectively as possible.


The International Medical Device Regulators Forum, or IMDRF, is a voluntary working group of international medical device experts whose purpose is to harmonize medical device standards and regulations. The IMDRF supersedes the Global Harmonization Task Force.


Installation Qualification, Operational Qualification, and Performance Qualification are terms that pertain to medical device software and equipment validation. IQ relates to the proper installment of software or equipment, OQ concerns meeting the necessary regulatory requirements, and PQ has to do with compliance of the software or equipment performance.


An Institutional Review Board, or IRB, is a body that oversees human medical research in the U.S. and ensures that the human rights of all subjects are protected. An IRB has the authority to approve or disapprove research or to request modifications to research practices.


The International Organization for Standardization, or ISO, is a non-governmental organization of experts providing voluntary international standards, based on the subject matter expertise of members, to enable and promote innovative solutions to worldwide challenges.

ISO 13485:2016

ISO 13485:2016 is the internationally harmonized standard for medical device quality management systems (QMS). To align with ISO 13485:2016, QMS contents should address the specific, applicable requirements outlined in the standard, in addition to the applicable regulatory requirements according to the markets where the medical device will be manufactured and marketed.

ISO 14971:2019

ISO 14971:2019 is the latest version of the international standard for medical device risk management. The globally recognized standard offers best practices for using a proactive approach to risk management throughout the entire lifecycle of a medical device.

ISO 9001

ISO 9001 is an international standard that specifies the requirements for a quality management system. Belonging under the umbrella of the ISO 9000 standard, 9001 is the only one that offers a certification pathway for manufacturers. This standard assumes a specialized focus on ensuring users receive good-quality products and services.


IVD refers to In Vitro Diagnostic devices. As defined in IVDR (EU) 2017/746, IVD can describe devices or equipment “intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.”


Manufacturer and User Facility Device Experience, or MAUDE, is a database for medical device electronic reporting (eMDR) submitted to the FDA by manufacturers, importers, device user facilities, health care professionals, patients, and consumers.


Medical Device Reporting, or MDR, refers to a surveillance tool maintained by FDA that is used to monitor the performance and safety of medical devices after being placed on the market. MDR provides voluntary reporting capabilities to both medical device manufacturers and consumers for public-use.


The Medical Device Single Audit Program, or MDSAP, is a program allowing medical device manufacturers to gain access into multiple global markets through one audit event. There are currently five active participating regions of MDSAP, including Australia, Brazil, Canada, Japan, and the United States.


Medical Device User Fee Amendments, or MDUFA, refers to changes made to the fee structure in which medical device companies are expected to pay to FDA in order to register their establishments and devices. These fees also apply to application or notification submissions made to the FDA.


A Medical Device Quality Management System, or MDQMS, is a quality management system built from the ground up for the medical device industry. Unlike a legacy QMS or ad hoc system, a MDQMS typically includes templates and workflows that align with medical device industry requirements and best practices.


Manufacturing Resource Planning, or MRP, is a way of compiling, organizing, and planning various activities carried out by a medical device manufacturer (or with any business). The method involves simulating hypothetical scenarios to ensure resources are being used effectively. This term has fallen out of use in recent years and may also be referred to as ERP.


A Notified Body, or NB, is a third-party auditing organization that assesses the quality and conformity of medical device products seeking market entry into the European Union.


A Nonconformance Report, or NCR, is used to document non-conforming material observed during quality control activities or inspection. A NCR details the identified issue(s) of nonconformance, the severity and impact of the non-conformance, how it occurred, and how nonconformance will be managed to prevent recurrence.


Nonsignificant Risk, or NSR, is a measure of risk as outlined by ISO 14971. Determining whether a risk is significant or nonsignificant involves assessing the probability of direct harm, probability of harm from not using the device, and probability of harm from misinformation.


Own Brand Labeling, or OBL, occurs when a manufacturer sells a medical device in the EU that already has a CE Marking and does so under its own brand.


An Original Equipment Manufacturer, or OEM, is an organization that produces goods which are used as subparts in products of a third-party company, which then sells the end products to consumers.


The European Commission requires manufacturers to designate at least one person with the requisite expertise in the field of medical devices from within their organization as the Person Responsible for Regulatory Compliance (PRRC).


Product Development, or PD, is the pre-market process of building a medical device. In the medical device industry, this process encompasses the design and development of a product.


Product Data Management, or PDM, is the handling of data as it relates to a medical device within a software system. Modern medical device companies often use PDM tools to compile product data and automate management protocols.


In the manufacturing sector, Product Lifecycle Management, or PLM, is a system for managing and overseeing the development and distribution of a product. This process applies to the inception, design, regulatory approval, manufacturing, marketing, and post-market phases of medical devices until the product is no longer on the market.


Premarket Approval, or PMA, is the regulatory pathway to market required for Class III devices under FDA regulations. The PMA submission process typically involves clinical trials with human participants, as well as laboratory testing, to demonstrate the safety and efficacy of the device.


Post-Market Surveillance, or PMS, is the process of monitoring a medical device after it has gained market entry for sale and distribution of use for use by patients within the marketplace. PMS involves gathering data and feedback on the performance of a device on the market, and it is a mandatory process for compliance with most regulations and standards, including 21 CFR Part 820, EU MDR, and ISO 13485:2016.


Proof of Principle, or POP and also known as Proof of Concept, is the demonstration that the initial concept behind a medical device is feasible. The POP typically includes criteria for success that must be met in order to proceed with product development.


Production Planning and Control, or PPC, is a process used to organize the production, including design and development activities, and the manufacture of a medical device. A PPC process is usually comprised of inputs, outputs, and control systems. Regulations for design and development planning are found under FDA CFR 21 Part 820.30.


Quality Assurance, or QA, is a method used to prevent defective, nonconforming products. QA professionals engage in activities intended to improve the product development and testing processes, as well as maintaining compliant marketing and distribution processes.

A quality management system can be considered as a QA tool itself, as it serves as a single source of truth for all quality policies and procedures for the final product.


While QA focuses on the process, Quality Control, or QC, focuses on the product. QC is system for identifying defects in a medical device during the post-production phase, prior to product distribution. The goal of quality control is to ensure the product conforms to specified requirements and will meet expected performance criteria upon end user interface. QC and QA are complementary aspects of a QMS.


A Quality Management System, or QMS, is an organizational tool for implementing and maintaining activities, documents, and tasks as it relates to responsibilities, procedures, processes, and resources. A QMS is instrumental in achieving regulatory compliance and in producing safe and effective medical devices. At minimum, a quality system should include design controls, risk management, document control and records management, and supplier management.


The Quality System Inspection Technique, also known as the QSIT method, is a type of FDA inspection that uses a top-down approach to reviewing the four main subsystems within a company's QMS. The top-down approach used by the FDA inspector begins with reviewing the company's procedures before drilling down into the quality records for those processes. The quality records serve as proof the company is following its written procedures.


A Quality System Record, or QSR, is a record that acts as a source file for all documentation, procedures, and records that are located within a QMS. Medical device companies can use their QSR as a reference to navigate other aspects of their QMS. QSR can also refer to Quality System Regulation, shown below.


The Quality System Regulation, or QSR, for medical devices in the U.S. is outlined in FDA 21 CFR Part 820. The QSR requirements are based on methods for facilities, and controls used for, carrying out all phases of processes throughout the lifecycle of a medical device. These aspects include design, manufacture, packaging, labeling, storing, installing, and servicing of medical devices intended for use by humans.


Regulatory Affairs, or RA, professionals in the medical device industry play a strategic role throughout the product lifecycle, such as ownership of a company's go-to-market strategy for satisfying legal requirements of product commercialization, regulatory submission protocol, and postmarket surveillance methods. The RA role serves a critical function for effectively communicating and executing appropriate regulatory strategies to ensure compliance.


Risk Analysis, or RA, is a method used in risk management to identify specific risks associated with a design, procedure, or process used in the manufacture of a medical device. The RA process will include identifying the medical device, the persons involved, the scope of the risk analysis, and relevant date(s). Preliminary hazard analysis, FMEA, and fault tree analysis are all methods used to carry out risk analysis for a medical device.


Risk Management, or RM, is a process used by medical device companies to identify, control, and prevent hazards and risks/sources of harm that might arise during the use of a medical device. The internationally recognized standard for medical device RM processes are outlined in ISO 14971:2019.


Research Use Only, or RUO, is a term used to indicate that a medical device product or instrument does not have an intended medical purpose and instead is to be used for research purposes only. Devices used for research in IVD product development are often labeled RUO.


Software as a Medical Device, or SaMD, is a class of software used for medical functions, without needing a hardware component to serve that function. An application or software that's used to diagnose, cure, prevent, or mitigate disease are all considered to be classes of SaMD.


A Supplier Corrective Action Request, or SCAR, is a formal notice sent to a supplier by a medical device company upon the observance of issues related to nonconforming products or materials. Such issues impact the quality of the provided goods, and the purpose of the SCAR is to solicit action from the supplier to identify and correct the issue(s) raised.


Substantial Equivalence, or SE, is a regulatory requirement by FDA for market clearance of new products through a 510(k) premarket submission. To declare substantial equivalence, a company must prove their device is as safe and effective as a similar predicate device. SE is required for regulatory submissions for which a premarket approval (PMA) is not required.


The Safe Medical Devices Act, or SMDA, is a law which passed in 1990 establishing HHS as the governing authority over device user facilities to report incidents in which a medical device may have caused or contributed to the serious injury, illness, or death of a patient.


A Standard Operating Procedure, or SOP, is an internal procedure created by an organization to standardize a routine process for ease of repeatable. A SOP is typically a written document comprised of a series of prescriptive instructions to be followed by individuals and teams. Medical device companies are required to create and maintain SOPs for routine processes as part of their QMS.


Statistical Process Control, or SPC, is a method used to control a process through the use of statistical techniques. This involves compiling data from a process and building cause and effect models to predict and account for various outcomes.


Significant Risk, or SR, is a measure of risk as defined by ISO 14971. Any device that poses a serious risk to the health or safety of a human subject is categorized as SR.


Single-Use Devices, or SUDs, are disposable devices intended to be used for a singular event or procedure for one patient only. These devices are to be disposed after use rather than sanitized and re-used.


Summary Technical Documentation, or STED, is format manufacturers can use to record required information about how a medical device was designed, developed, and manufactured for submission to a Regulatory Authority or Notified Body to demonstrate conformity. The STED format represents the documentation required for Technical Files.


A Technical File, or Design Dossier  for Class III devices, includes specific details about a medical device's design, composition, intended use, function, and clinical evaluation. TF are a key requirement of obtaining CE marking for a device.


Unique Device Identification, or UDI, is a system established by the FDA to catalog and identify each individual device for sale in the U.S. market by assigning a custom identifier that can be read by both humans and machines. A UDI is distinct from a Universal Product Code (UPC), as the UDI is used to identify a medical device on the FDA website via the AccessGUDID portal.


A Universal Product Code, or UPC, is a code printed on retail packaging consisting of a barcode and a 12-digit number. The code can be used to track inventory for retailers and is considered to be an alternative tracking method to UDI, the official identification system used by FDA.


Verification and Validation, also known as V&V, are activities for testing and confirming whether a medical device meets the design procedures and is ready to be released for manufacture. Design verification ensures you designed the device correctly and design validation ensures you designed the correct device. These processes tend to involve careful tests, trials, and analyses.


Voluntary Action Indicated, or VAI, is a term used by the FDA in establishment inspection reports (EIR) to indicate regulatory action is not required, following the observance of objectionable conditions or practices during an inspection. On the contrary, Official Action Indicated (OAI) would indicate regulatory or administrative action is required by FDA to correct an issue found during an inspection.


A Warning Letter (WL) is an official notice made by FDA in response to regulatory violations that have been escalated from a 483 observation. Violations may include anything from wrongful claims about the device to missing design controls. A WL will provide a detailed explanation of the violation and what is required of companies for a corrective action plan.


Work in Progress, or WIP, is a term used to refer to partially finished goods in manufacturing or within a design history record (DHR). Inventory that has entered the manufacturing process and can no longer be classed as raw materials but is not yet a finished product is classed as WIP.

The information provided in this article is for educational purposes only and is not intended to support the safety or effectiveness of any medical device, or diagnose, treat, cure, audit, procedure, quality standard or prevent any disease.

Audit Supplier Recognition by Made-in-China

Audit Supplier Recognition by Made-in-China

Today's customers expect nothing less than products of the highest quality, and it is incumbent on all manufacturers to assure this expectation is met. A proven technique for checking whether a manufacturing process is in control is a manufacturing audit.

A manufacturing audit is a comprehensive inspection of a process to determine whether it is performing satisfactorily. A manufacturing audit is usually limited to a small portion of units produced, but the manufacturing processes involved are reviewed thoroughly. An audit does not replace normal quality control efforts, but supplements them.

Medical audit is a systematic approach to peer review of medical care in order to identify opportunities for improvement and provide a mechanism for realizing them. Medical audit and clinical audit are often used interchangeably, but clinical audit might be considered to cover all aspects of clinical care-for example, nursing and the role of paramedical staff-whereas medical audit relates to practices initiated directly by doctors. It complements and may partly overlap financial audit, utilization review, and management of resources, but is primarily clinical, not managerial; its focus is the process and results of medical care rather than the use of resources and it is the responsibility of doctors rather than managers.

There are many reasons for conducting a manufacturing audit:

  • Assures procedures reflect actual practice (what we say is what we do);
  • Uncovers inaccuracies so they can be quickly corrected;
  • Reveals the consistency of a process (from person to person, or day to day);
  • Demonstrates a proactive approach to process improvement; and
  • Encourages ongoing corrective action.

Kaiyan Medical got another audit supplier recognition by Made-in-China. We like to keep our audits and quality standards to the top in order to assure the best experience for our customers and clients


Introduction to the Medical Device Single Audit Program (MDSAP)

Introduction to the Medical Device Single Audit Program (MDSAP)

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a workgroup to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is a program that conducts a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Why was the MDSAP developed?

The MDSAP was developed to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems. The idea is to promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. Also, in the longer term, promote greater alignment of regulatory approaches and technical requirements based on international standards and best practices

Which Regulatory Authorities are part of the MDSAP?

The MDSAP was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). All regulatory authorities participating in the MDSAP are equal partners in the program.

Which manufacturers are eligible for an MDSAP audit?

Any manufacturer of medical devices is eligible. However, each regulatory authority may establish exclusion criteria for some manufacturers. It is important to note that manufacturers that participate in the MDSAP program are responsible for securing and maintaining a contract with an MDSAP recognized auditing organization. In other words, medical device manufacturers are responsible for paying for MDSAP audits conducted by an auditing organization.

No. The MDSAP audit model was developed to cover existing requirements from the Regulatory Authorities participating in the M

Does the MDSAP add requirements for the manufacturer?

No. The MDSAP audit model was developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP. The program does not add any new requirements to existing requirements from ISO 13485.

What are the potential benefits?

  1. The MDSAP reduces the overall number of audits or inspections and optimizes the time and resources expended on audit activities.
  2. Reduce FDA routine inspections and minimize manufacturing plant and personnel disruptions.
  3. Minimize medical device manufacturer disruptions due to multiple regulatory audits.
  4. Provide predictable audit schedules (agendas with opening and completion dates).
  5. Consistent auditing from a single source for multiple regulatory requirements.
  6. As a longer-term goal, it is expected that the program will enhance confidence in the reliability of third-party audits.
  7. Some participating regulatory authorities will use MDSAP audit outcomes as an alternative to their own inspections to process applications for medical device marketing authorization.
  8. MDSAP may be seen as evidence of a medical device manufacturer’s commitment to quality management systems for product quality and regulatory compliance.

What are the costs associated with MDSAP audits

The cost of conducting an MDSAP audit is dictated by the commercial arrangement between the medical device manufacturer and the authorized MDSAP auditing organization.

COVID-19 Remote Audits

The spread of Covid-19 globally has resulted in the imposition of quarantine orders and travel restrictions that are affecting the ability of auditing organizations to perform MDSAP audits.

On-site audits can only be substituted with remote audits where travel restrictions or social/physical distancing as a result of the pandemic prevent on-site audits from occurring.

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For more detailed information about MDSAP please take a look at their documentation.

Useful links:

  1. MDSAP Assessment Procedures and Forms
  2. International Medical Device Regulators Forum
  3. MDSAP audits during COVID-19
  4. Auditing Organization Availability to Conduct MDSAP Audits
  5. MDSAP Regulatory Authority Contact Information