How can dFMEA and ISO14971 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 why 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 ISO4971, and how Greenlight Guru software aligns with ISO14971. 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.

Some of the highlights of today’s show include:

Understanding risk management in medical device design
Importance of collaboration between dFMEA and ISO4971
Exploring ISO14971 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 ISO14971
Benefits of tools like dFMEA and fault tree analysis
Mapping dFMEA and ISO14971 for FDA review

Links:

Quotes:

“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’ve identified, ok, here’s the serious harms we need to avoid." -- Wade Schroeder

#325 The Role of dFMEAs in Risk Management for Medical Devices

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#325 The Role of dFMEAs in Risk Management for Medical Devices