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Last updated on 2024年11月2日

How do you keep up with the latest trends and innovations in V&V testing in medical device industry?

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Verification and validation (V&V) testing is a crucial part of ensuring the safety, quality, and effectiveness of medical devices. However, the medical device industry is constantly evolving and innovating, which means that V&V testers need to keep up with the latest trends and best practices. In this article, you will learn some tips and strategies to stay updated and informed about the current and emerging challenges and opportunities in V&V testing in medical device industry.

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Troels Forchhammer

Principal Scientist, Test Engineering @ Coloplast | Product Development, Testing & Design Verification
Antonio Bartolozzi

Contract Professor @ University of Trieste | MD Auditor | Medical device software design
Adarsh S Kothari

Medical Devices | Project Management (PMP)? | Verification & Validation | Test Management | Six Sigma Quality (GB)? |…

1 Follow industry standards and guidelines

One of the most important ways to keep up with the latest trends and innovations in V&V testing in medical device industry is to follow the relevant industry standards and guidelines. These include the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the Food and Drug Administration (FDA), and the European Union Medical Device Regulation (MDR). These standards and guidelines provide the framework and requirements for conducting V&V testing in a consistent, compliant, and reliable manner. They also reflect the current state of the art and the best practices in the field. By staying updated and familiar with these standards and guidelines, you can ensure that your V&V testing meets the expectations and needs of the regulators, customers, and stakeholders.

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Antonio Bartolozzi

Contract Professor @ University of Trieste | MD Auditor | Medical device software design
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WARNING. Let's not get confused please. V&V Tests are used in medical devices for Safety and Security reasons. When it comes to safety tests, innovation and trends have nothing to do with it. In fact, I would say they can be harmful. Innovating excessively leads to serious safety problems. If we talk about security, innovation and trends make sense: in fact, hackers are constantly innovating and there are trends in attacks. As far as standards are concerned, they are part of the state of the art, so they are "almost" mandatory by law, but they certainly do not serve to innovate or follow trends. So the answer to the question is: no, they are not needed for innovation and following trends but they are essential for compliance.

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Adarsh S Kothari

Medical Devices | Project Management (PMP)? | Verification & Validation | Test Management | Six Sigma Quality (GB)? | Quality Management
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In my experience, V&V testing of medical devices is purely based on product & process standards and their guidance to ensure safety and effectiveness. To keep updated with latest trends and innovations in medical device testing, 1.Follow the latest compliance standard revisions wrt class of medical device 2.With the emerging of AI, Cybersecurity, Cloud apps etc., get to know on the regulations, network with industry experts, attend conferences, blogs, technical groups, forums etc. 3.Explore usage of new tools and techniques to minimize test cycles, better test coverage, traceability and documentation. 4.Continuous training on new test methods, test technologies and domain standards 5.Build CoE team with V&V best practices & test automation.

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Troels Forchhammer

Principal Scientist, Test Engineering @ Coloplast | Product Development, Testing & Design Verification
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One of the greatest boosts that I have had, personally, has been to engage in the development and update of international consensus standards (I have worked with a number of standards under ISO/TC 84, "Devices for administration of medicinal products and catheters"). For an organisation with the capacity (and knowledge) to engage in the working groups that develop the international standards for their products, the return is immeasurable in terms of understanding industry trends, of competence development of their employees, and in terms of understanding the standards and how best to implement them. Very highly recommended!

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2 Join professional networks and communities

Another way to keep up with the latest trends and innovations in V&V testing in medical device industry is to join professional networks and communities that are dedicated to this topic. These include online platforms, forums, blogs, podcasts, webinars, newsletters, magazines, and social media groups. These networks and communities can provide you with valuable insights, tips, experiences, feedback, and resources from other V&V testers, experts, and practitioners. They can also help you to exchange ideas, ask questions, share challenges, and learn from best practices. By joining these networks and communities, you can expand your knowledge, skills, and network in the V&V testing domain.

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Troels Forchhammer

Principal Scientist, Test Engineering @ Coloplast | Product Development, Testing & Design Verification
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In addition to the list of networks and communities in the main article, I would recommend joining both local professional groups for experience sharing, as well as international societies such as e.g. the AAMI.

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3 Attend training courses and events

A third way to keep up with the latest trends and innovations in V&V testing in medical device industry is to attend training courses and events that are relevant to this field. These include online or offline courses, workshops, seminars, conferences, symposiums, and exhibitions. These training courses and events can help you to update your V&V testing knowledge, skills, and tools. They can also expose you to the latest research, developments, technologies, and innovations in the medical device industry. By attending these training courses and events, you can enhance your competence, confidence, and credibility as a V&V tester.

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4 Follow thought leaders and influencers

A fourth way to keep up with the latest trends and innovations in V&V testing in medical device industry is to follow thought leaders and influencers who are influential and respected in this field. These include academics, researchers, consultants, authors, speakers, trainers, and mentors. These thought leaders and influencers can provide you with cutting-edge insights, opinions, trends, and predictions about the future of V&V testing in medical device industry. They can also inspire you to think creatively, critically, and strategically about your V&V testing approach and goals. By following these thought leaders and influencers, you can stay ahead of the curve and learn from their expertise and experience.

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5 Experiment with new tools and techniques

A fifth way to keep up with the latest trends and innovations in V&V testing in medical device industry is to experiment with new tools and techniques that can improve your V&V testing efficiency, effectiveness, and quality. These include software tools, hardware devices, testing methods, frameworks, models, and metrics. These tools and techniques can help you to automate, optimize, simplify, or enhance your V&V testing processes, activities, and outcomes. They can also help you to address the specific challenges and needs of your medical device projects, such as complexity, variability, risk, usability, interoperability, or security. By experimenting with new tools and techniques, you can discover new ways of doing V&V testing that can add value to your medical device products and services.

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6 Seek feedback and improvement

A sixth way to keep up with the latest trends and innovations in V&V testing in medical device industry is to seek feedback and improvement from your V&V testing results, performance, and quality. This includes collecting, analyzing, and reporting data, metrics, and indicators that can measure your V&V testing effectiveness, efficiency, and quality. This also includes soliciting, receiving, and acting on feedback from your stakeholders, customers, users, peers, managers, and auditors. This feedback and improvement can help you to identify your strengths, weaknesses, opportunities, and threats in your V&V testing practice. They can also help you to implement corrective and preventive actions, continuous improvement initiatives, and lessons learned processes. By seeking feedback and improvement, you can ensure that your V&V testing is aligned with the latest trends and innovations in medical device industry.

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7 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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Antonio Bartolozzi

Contract Professor @ University of Trieste | MD Auditor | Medical device software design
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I would say the question is misleading. It is useful to ask yourself how effective V&V tests are carried out. Well, for this it is necessary to follow the design rules, for example, it is necessary to know what defense in depth is, architectural segregation, the usefulness of LOGs. So don't follow either trends or innovations for tests: to do them well you need to have a testable architecture, but this discussion takes us far....

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How do you keep up with the latest trends and innovations in V&V testing in medical device industry?

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1 Follow industry standards and guidelines

2 Join professional networks and communities

3 Attend training courses and events

4 Follow thought leaders and influencers

5 Experiment with new tools and techniques

6 Seek feedback and improvement

7 Here’s what else to consider

Verification and Validation (V&V)

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