Part 1/3 - The Design History File

The beginning

The food and drug administration(FDA) quality system requirements for all medical device companies are documented in the federal code of regulations, under 21 CFR part 820.

In 1990, the FDA mandated the design history file (DHF) as part of the safe medical devices act. It contains all of the product development documentation pertaining to a finished medical device. The DHF was the last step in the design controls process mandated by the FDA in 21 CFR Part 820.

Overview of 21 CFR part 820

The FDA’s mandate for quality systems states that each medical device company must establish and maintain a quality system that meets the requirements of its regulations and is appropriate for the medical device they manufacture. Differently classified medical devices may have different requirements under the quality system guidelines. For example, Class I medical devices (with some exceptions) are exempt from the design controls portion of the regulations, but in general, the guidelines must be satisfied to permit the sale of a medical device within the United States.

Medical device companies should consider the quality system regulations as their “key to admission” into the medical devices marketplace.

Image for post

DHF

Subsection j) of 21 CFR part 820 says:

Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”

DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development while the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF go a long way towards helping you pass your next FDA audit.

Here are some key interpretations of the DHF guidance that medical device companies should take note of:

  • A DHF must be maintained for each type of device that you manufacture. For similar versions of the same device, you can include all of the data in a single DHF.
  • The DHF demonstrates that the device was developed in accordance with both the design plan and the requirements of this part. Your design plan must reflect compliance with the design controls process and should be included as part of the DHF.
  • The DHF must either contain or reference the necessary documents, which means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials.

What belongs in your DHF?

Below, we’ve listed the steps of the design controls process and what documents should be included with each step:

  1. Design input: include your design plan document, developed according to this part.
  2. Design output: Design outputs are the results of the design and engineering efforts. These are normally the final specifications for the device. The outputs are normally documented in models, drawings, engineering analyses, and other documents.
  3. Design review: is a formal review of the medical device design by representatives of each design function participating in the design efforts as well as other interested parties. The design review must be documented in the DHF and include review date, participants, design version/revision reviewed, and review results.
  4. Design verification: is the process that confirms that the design output conforms to the design input. Design verification should demonstrate that the specifications are the correct specifications for the design. Design verification must be documented in the DHF and include the verification date, participants, design version/revision verified verification method and verification results.
  5. Process validation: is the process in which the device design is validated using initial/low volume production processes. The purpose of the process validation is to confirm that the design functions according to design inputs when produced using normal production processes rather than prototype processes.
  6. Design validation: Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
  7. Design transfer: Design transfer is the process in which the device design is translated into production, distribution, and installation specifications.
  8. Design changes: Design changes is the process in which the design changes are identified and documented. Also known as engineering change or enterprise change.

References

  1. Harnack, Gordon (1999). Mastering and Managing the FDA Maze: Medical Device Overview. American Society for Quality. ISBN 9780873894555. Retrieved January 13, 2017.[page needed]
  2. FDA Staff (October 7, 1966). “Part 820 — Quality System Regulation, Subpart C — Design Controls, § 820.30 Design Controls”. Federal Register. 61 (195): 52657. ISBN 9781932074109. Retrieved January 13, 2017. Also available in hardcopy, as FDAnews (2003). Device Inspections Guide. Washington, DC: Washington Business Information. p. 52657. ISBN 1932074104.

External links

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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.

Conclusion

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.

Sources:

· 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:

Part 1/3 - The Design History File

Part 1/3 - The Design History File

The beginning

The food and drug administration(FDA) quality system requirements for all medical device companies are documented in the federal code of regulations, under 21 CFR part 820.

In 1990, the FDA mandated the design history file (DHF) as part of the safe medical devices act. It contains all of the product development documentation pertaining to a finished medical device. The DHF was the last step in the design controls process mandated by the FDA in 21 CFR Part 820.

Overview of 21 CFR part 820

The FDA’s mandate for quality systems states that each medical device company must establish and maintain a quality system that meets the requirements of its regulations and is appropriate for the medical device they manufacture. Differently classified medical devices may have different requirements under the quality system guidelines. For example, Class I medical devices (with some exceptions) are exempt from the design controls portion of the regulations, but in general, the guidelines must be satisfied to permit the sale of a medical device within the United States.

Medical device companies should consider the quality system regulations as their “key to admission” into the medical devices marketplace.

Image for post

DHF

Subsection j) of 21 CFR part 820 says:

Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”

DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development while the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF go a long way towards helping you pass your next FDA audit.

Here are some key interpretations of the DHF guidance that medical device companies should take note of:

  • A DHF must be maintained for each type of device that you manufacture. For similar versions of the same device, you can include all of the data in a single DHF.
  • The DHF demonstrates that the device was developed in accordance with both the design plan and the requirements of this part. Your design plan must reflect compliance with the design controls process and should be included as part of the DHF.
  • The DHF must either contain or reference the necessary documents, which means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials.

What belongs in your DHF?

Below, we’ve listed the steps of the design controls process and what documents should be included with each step:

  1. Design input: include your design plan document, developed according to this part.
  2. Design output: Design outputs are the results of the design and engineering efforts. These are normally the final specifications for the device. The outputs are normally documented in models, drawings, engineering analyses, and other documents.
  3. Design review: is a formal review of the medical device design by representatives of each design function participating in the design efforts as well as other interested parties. The design review must be documented in the DHF and include review date, participants, design version/revision reviewed, and review results.
  4. Design verification: is the process that confirms that the design output conforms to the design input. Design verification should demonstrate that the specifications are the correct specifications for the design. Design verification must be documented in the DHF and include the verification date, participants, design version/revision verified verification method and verification results.
  5. Process validation: is the process in which the device design is validated using initial/low volume production processes. The purpose of the process validation is to confirm that the design functions according to design inputs when produced using normal production processes rather than prototype processes.
  6. Design validation: Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
  7. Design transfer: Design transfer is the process in which the device design is translated into production, distribution, and installation specifications.
  8. Design changes: Design changes is the process in which the design changes are identified and documented. Also known as engineering change or enterprise change.

References

  1. Harnack, Gordon (1999). Mastering and Managing the FDA Maze: Medical Device Overview. American Society for Quality. ISBN 9780873894555. Retrieved January 13, 2017.[page needed]
  2. FDA Staff (October 7, 1966). “Part 820 — Quality System Regulation, Subpart C — Design Controls, § 820.30 Design Controls”. Federal Register. 61 (195): 52657. ISBN 9781932074109. Retrieved January 13, 2017. Also available in hardcopy, as FDAnews (2003). Device Inspections Guide. Washington, DC: Washington Business Information. p. 52657. ISBN 1932074104.

External links

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.

483 OBSERVATION

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.

510(K) PREMARKET NOTIFICATION

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 (ALM)

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.

AUDITING ORGANIZATION (AO)

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.

APPROVED SUPPLIER LIST (ASL)

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.

BILL OF MATERIALS (BOM)

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.

COMPETENT AUTHORITY (CA)

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.

CONFORMITY ASSESSMENT (CA)

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)

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 (CAPA)

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.

CE MARKING (CE MARK)

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).

EUROPEAN COMMITTEE FOR STANDARDIZATION (CEN)

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.

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

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.

CLINICAL EVALUATION REPORT (CER)

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 (COQ)

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 (CSV)

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 (CGMP)

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.

DOCUMENT CHANGE ORDER (DCO)

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.

DE NOVO

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.

DEMING CYCLE

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 (DC)

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.

DESIGN DOSSIER (DD)

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.

DESIGN OF EXPERIMENT (DOE)

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.

DESIGN FOR MANUFACTURE (DFM)

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.

DESIGN HISTORY FILE (DHF)

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.

DEVICE HISTORY RECORD (DHR)

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.

DEVICE MASTER RECORD (DMR)

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.

DOCUMENT MANAGEMENT SYSTEM (DMS)

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.

ENGINEERING CHANGE ORDER (ECO)

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.

ESTABLISHMENT INSPECTION REPORT (EIR)

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 (ERP)

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.

IN VITRO DIAGNOSTIC REGULATION (IVDR)

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).

EU MEDICAL DEVICE DIRECTIVE (MDD)

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 MEDICAL DEVICE REGULATION (EU MDR)

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.

EUROPEAN DATABASE ON MEDICAL DEVICES (EUDAMED)

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.

FOOD AND DRUG ADMINISTRATION (FDA)

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 (FMEA)

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 (FTA)

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 (FTO)

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.

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS (GSPR)

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 (HID)

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.

INVESTIGATIONAL DEVICE EXEMPTION (IDE)

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 (IFU)

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.

INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF)

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 (IQ), OPERATIONAL QUALIFICATION (OQ), AND PERFORMANCE QUALIFICATION (PQ)

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.

INSTITUTIONAL REVIEW BOARD (IRB)

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.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)

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.

IN VITRO DIAGNOSTIC (IVD) DEVICES

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 (MAUDE)

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 (MDR)

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.

MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)

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 (MDUFA)

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.

MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM (MDQMS)

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 (MRP)

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.

NOTIFIED BODY (NB)

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.

NONCONFORMANCE REPORT (NCR)

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 (NSR)

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 (OBL)

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.

ORIGINAL EQUIPMENT MANUFACTURER (OEM)

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.

PERSONS RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

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 (PD)

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 (PDM)

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.

PRODUCT LIFECYCLE MANAGEMENT (PLM)

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 (PMA)

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 (PMS)

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 (POP)

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 (PPC)

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 (QA)

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.

QUALITY CONTROL (QC)

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.

QUALITY MANAGEMENT SYSTEM (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.

QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT)

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.

QUALITY SYSTEM RECORD (QSR)

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.

QUALITY SYSTEM REGULATION (QSR)

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 (RA)

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 (RA)

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 (RM)

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 (RUO)

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 (SAMD)

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.

SUPPLIER CORRECTIVE ACTION REQUEST (SCAR)

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 (SE)

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.

SAFE MEDICAL DEVICES ACT (SMDA)

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.

STANDARD OPERATING PROCEDURE (SOP)

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 (SPC)

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 (SR)

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 (SUDS)

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 (STED)

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.

TECHNICAL FILE (TF)

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 (UDI)

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.

UNIVERSAL PRODUCT CODE (UPC)

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 (V&V)

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 (VAI)

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.

WARNING LETTER (WL)

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 (WIP)

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

https://www.bmj.com/content/bmj/299/6697/498.full.pdf