Hardware Podcasts

Risk Management from a Regulatory & Product Development Point of View

Global Medical Device Podcast · 7 Nov 2019 · 22m · Episode 4

What this episode covers

Host John Speer and guest Mike Drues, president of Vascular Sciences, discuss the complexities of risk management in medical device development, specifically focusing on the tension between regulatory documentation and product liability. They analyze ISO 14971 and TR 24971 as frameworks, highlighting the dilemma of addressing off-label use in risk assessments to avoid higher liability exposure. The conversation covers strategies for limiting discussion to on-label risks while still considering unintentional misuse, and concludes with advice on navigating FDA interactions regarding intended use.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
ISO 14971, TR 24971, FMEA, FDA

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