The Role of dFMEA in Risk Management for Medical Devices
Автор: Greenlight Guru
Загружено: 2025-09-03
Просмотров: 147
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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