Hardware Podcasts

#383: What Standards Apply to My Device?

Global Medical Device Podcast · 19 Sept 2024 · 51m · Episode 383

What this episode covers

Leo Eisner, founder of Eisner Safety Consultants and the 'IEC 60601 Guy,' explains how to identify and apply medical device standards like IEC 60601 and ISO 15223. He outlines a process for determining applicable standards based on intended use and target markets, emphasizing that standards serve as critical design inputs. Eisner warns against delaying compliance reviews, noting that late integration causes costly design risks, recalls, and market delays. He also advises startups on cost-effective ways to access standards and stay updated through regulatory databases and committee participation.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Eisner Safety Consultants, Underwriters Labs, ANSI, Techstreet, Accuris, Intertech Inform, FDA, ISO, IEC
Tools
MedBoard
Also
IEC 60601, ISO 15223

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