Hardware Podcasts

#362: Managing Risk in Clinical Investigations

Global Medical Device Podcast · 25 Apr 2024 · 39m · Episode 362

What this episode covers

Helene Quie, a medical device regulatory expert, explains the dual nature of risk management in clinical investigations, distinguishing between residual product safety risks and procedural risks inherent in study protocols. She emphasizes the need for measurable, data-driven benefit-risk assessments to satisfy ethics committees and competent authorities, particularly under the EU MDR. Quie highlights the operational challenges of enrolling vulnerable patient populations, such as children or acute patients, and the regulatory confusion surrounding the integration of AI in medical devices.

Most relevant to

early-stage companies

Topics

Mentioned

Also
Helene Quie, Etienne Nichols, EU MDR, MDD, FDA, ISO 14155

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