Hardware Podcasts

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Global Medical Device Podcast · 20 May 2020 · 36m · Episode 147

What this episode covers

Kevin Coker, co-founder and CEO of Proxima Clinical Research, explains the clinical evaluation and validation requirements for Software as a Medical Device (SaMD). He details the three pillars of clinical evaluation—scientific, analytical, and clinical validity—and discusses how IMDRF categories determine the need for independent review. The conversation covers strategies for generating evidence, including the use of real-world evidence and post-market surveillance to satisfy FDA requirements without always requiring prospective clinical trials.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Proxima Clinical Research, Greenlight Guru
Products
Zantac
Also
IMDRF, FDA, EU MDR

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