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What are the most effective ways to implement APQP in medical device development?

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Advanced Product Quality Planning (APQP) is a structured approach to ensure that medical devices meet customer requirements and regulatory standards throughout the development process. APQP can help you reduce risks, costs, and errors, and improve customer satisfaction and quality performance. But how can you implement APQP effectively in your medical device development projects? Here are some tips to help you.

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1 Align your APQP with ISO 13485

ISO 13485 is the international standard for quality management systems for medical devices. It covers the requirements for planning, design, development, production, installation, and servicing of medical devices. By aligning your APQP with ISO 13485, you can ensure that you follow the best practices and comply with the relevant regulations. You can use the ISO 13485 clauses as a guide for your APQP phases and activities, and map your APQP deliverables to the ISO 13485 documentation requirements.

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Subhi Saadeh

Combination Product QA @Gilead?? ??| Combinate Podcast Host ?? | Speaker | International WG Chair @CPC ??| International Harmonization Advocate ?? | Ironman/Ultramarathoner/Lifter ??♂????| Simplifying by Combinating ??
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APQP tools can feed into the ISO13485 requirement satisfaction pretty easily. For example many of the APQP tools can feed into ISO's requirements for design and development planning. Production Part Approval Process(PPAP) can be used to establish objective evidence for ISO13485's requirement for verification of purchased product. While not specifically mentioned in detail in ISO13485, risk management tools often used in industry like all the FMEA variants find roots in APQP. Lastly, SPC(Monitoring), customer satisfaction, and improvement are aligned between APQP and ISO13485.

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Ronald K. McIntire

Writer, Creator, Lifelong Learner, Motivator. Im here to help.
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MedTech & APQP: A Teamwork Win! Boost efficiency & safety: Early risk ID + streamlined processes = faster, cheaper development & protected patients. Get everyone on board: Executives lead, managers empower, teams see the impact & transparency thrives. Champions: Your secret weapon! Find passionate leaders to guide & advocate across departments. Join the movement! Share your #MedTech #APQP experiences & build better devices together.

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Nidhi Patel

Quality Assurance & Control | HACCP & Six Sigma Green Belt Certified | Audit & Quality Management | Regulatory Affairs
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In my opinion to implement APQP effectively in medical device development while aligning with ISO 13485: Understand ISO 13485 requirements thoroughly. Align APQP phases with relevant ISO 13485 clauses. Map APQP deliverables to ISO 13485 documentation requirements. Integrate risk management activities into APQP. Foster cross-functional team collaboration. Establish robust document control procedures. Implement continuous improvement and corrective actions. Provide training for personnel involved in APQP. These steps ensure compliance with regulations, enhance product quality, and mitigate risks.

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2 Involve cross-functional teams and stakeholders

APQP is not a solo activity. It requires the collaboration and communication of cross-functional teams and stakeholders, such as engineering, quality, manufacturing, marketing, regulatory, and customers. By involving them early and often in your APQP process, you can gain valuable insights, feedback, and support for your medical device development. You can also avoid potential conflicts, misunderstandings, and delays that could affect your quality outcomes. You can use tools such as project management software, quality management software, and online platforms to facilitate your team and stakeholder engagement.

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3 Apply risk management throughout APQP

Risk management is a key aspect of APQP, as it helps you identify, analyze, evaluate, and mitigate the potential hazards and failures that could affect your medical device quality and safety. You should apply risk management throughout your APQP process, from the planning phase to the validation phase. You should use risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis), and HACCP (Hazard Analysis and Critical Control Points) to systematically assess and control your risks. You should also document and update your risk management activities and results according to ISO 14971, the international standard for risk management of medical devices.

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Subhi Saadeh

Combination Product QA @Gilead?? ??| Combinate Podcast Host ?? | Speaker | International WG Chair @CPC ??| International Harmonization Advocate ?? | Ironman/Ultramarathoner/Lifter ??♂????| Simplifying by Combinating ??
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ISO14971 interestingly does not outline specific expectations in terms of deliverables for large parts of the standard. Most companies find themselves using FMEA to outline Failure Modes, however for medical devices it's important to understand what the risk is to patient which where Hazard Analysis(HA) and RACT(Risk Assessment and Control Tables) can be tremendously helpful. FMEA's find where the product issues may occur from sources related to design, process, application, use, equipment, software, etc with the HA finding what all could go wrong with a patient. RACT looks at the hazards/harms that arises from the failures and ensures that appropriate risk control measures are implemented with VOI/VOE being required for those per ISO14971.

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4 Use data-driven decision making and continuous improvement

APQP is not a one-time event. It is a dynamic and iterative process that requires data-driven decision making and continuous improvement. You should use data and metrics to monitor, measure, and evaluate your medical device quality performance and customer satisfaction. You should also use data to identify gaps, issues, and opportunities for improvement in your APQP process. You should use tools such as control charts, histograms, Pareto charts, and fishbone diagrams to analyze and visualize your data. You should also use tools such as PDCA (Plan-Do-Check-Act) cycle, 8D (Eight Disciplines) method, and CAPA (Corrective and Preventive Action) process to implement and verify your improvement actions.

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5 Leverage APQP training and resources

APQP is a complex and challenging process that requires knowledge, skills, and experience. If you want to implement APQP effectively in your medical device development, you should leverage the available training and resources that can help you learn and apply the APQP principles and practices. You can find online courses, webinars, books, guides, templates, checklists, and software that can help you understand and execute APQP in your medical device projects. You can also consult experts, mentors, or peers who have experience and expertise in APQP for medical devices.

Implementing APQP in your medical device development can help you achieve higher quality and customer satisfaction, while reducing risks, costs, and errors. By following these tips, you can make your APQP process more efficient, effective, and successful.

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Subhi Saadeh

Combination Product QA @Gilead?? ??| Combinate Podcast Host ?? | Speaker | International WG Chair @CPC ??| International Harmonization Advocate ?? | Ironman/Ultramarathoner/Lifter ??♂????| Simplifying by Combinating ??
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I think training is important when it comes to APQP. I found that for PPAP specifically, we would train our suppliers on our expectations to ensure that they understood all of our expectations to satisfy PPAP. Most automotive manufacturers have some kind of training framework and publicly available manuals that are shared with suppliers to ensure that quality requirements are understood in terms of PPAP(which is an APQP element).

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Gholamreza Golshani

Electrical Engineer ?? | Content Manager?? | Creative Content Creator ? | Content Marketing ?? | I help people promote their efficiency at work.??
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To me, in my opinion, implementing APQP in medical device development involves forming cross-functional teams, defining customer requirements, conducting risk management, planning design and development activities, managing suppliers, verifying and validating designs, implementing change control processes, controlling documents, fostering continuous improvement, and providing training. By following these steps, medical device manufacturers can ensure the quality, safety, and regulatory compliance of their products throughout the development process.

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What are the most effective ways to implement APQP in medical device development?

1

2

3

4

5

6

1 Align your APQP with ISO 13485

2 Involve cross-functional teams and stakeholders

3 Apply risk management throughout APQP

4 Use data-driven decision making and continuous improvement

5 Leverage APQP training and resources

6 Here’s what else to consider

Quality Management

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What are the most effective ways to implement APQP in medical device development?

1

2

3

4

5

6

1 Align your APQP with ISO 13485

2 Involve cross-functional teams and stakeholders

3 Apply risk management throughout APQP

4 Use data-driven decision making and continuous improvement

5 Leverage APQP training and resources

6 Here’s what else to consider

Quality Management

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