How do dFMEA and ISO 14971 work together? This topic is controversial but essential, and today’s guest is more than capable of tackling it. Risk management is one of the top 3 reasons the FDA issues 483s, so it’s important to understand.
In today’s episode, Wade Schroeder, a medical device guru with a master's degree from the University of Dayton, shares his insights on risk management in medical device design. Wade discusses the importance of a top-down approach, the collaboration between dFMEA and ISO 14971, and how Greenlight Guru software aligns with ISO 14971. The conversation covers the value of considering the patient perspective, the complexities of regulatory, ethical, and business obligations, and the benefits of tools like dFMEA and fault tree analysis.
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Some of the highlights of this episode include:
- Understanding risk management in medical device design
- Importance of collaboration between dFMEA and ISO 14971
- Exploring ISO 14971 and FDA consensus standards
- A top-down approach to risk management in medical device design
- Considering the patient perspective in the risk management process
- The complexity of regulatory, ethical, and business obligations
- ISO14971 as a regulatory burden ensuring patient safety
- How Greenlight Guru is designed to align with ISO 14971
- Benefits of tools like dFMEA and fault tree analysis
- Mapping dFMEA and ISO 14971 for FDA review
Links:
Memorable quotes from Wade Schroeder:
“Put simply, it's all about telling the story of what could go wrong with your device and what harms could that lead to." -- Wade Schroeder
"Before you even start your design, you need to identify the serious harms we need to avoid." -- Wade Schroeder
Transcript
TBD!
About the Global Medical Device Podcast:
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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
