Hardware Podcasts

148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner

Let's Combinate · 7 Aug 2024 · 26m

What this episode covers

Leo Eisner, founder of Eisner Safety Consultants, explains how to assess the applicability of medical device standards like IEC 60601 and ISO 15223 by analyzing product environment, intended use, and market-specific regulations. He advocates for documenting these assessments in design input documents and breaking down standards into atomic requirements to ensure clear traceability in the Design History File. The discussion highlights the challenges small and large companies face in interpreting standards, the importance of leveraging existing Test Report Forms (TRFs) where available, and the critical need for early, systematic research to avoid costly regulatory delays.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Eisner Safety Consultants
Also
IEC 60601, ISO 15223, ISO 20417, ISO 15747, FDA, MDR, CB Scheme

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