Template: Checklist: User Needs Review

Sven Piechottka • IEC 62304 Templates • Published June 27, 2023

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Checklist User Needs Review

ISO 13485:2016 Section	Document Section
7.3.2	(Al)

Classes	IEC 62304:2006 Section	Document Section
A, B, C	5.1.8	(All)

1. Summary

With this checklist we verify the completeness and consistency of User Needs.

Relevant documents:

User Needs (Doc-ID)

2. Checklist

Checklist Items	Yes	No	Comment
The user needs are complete.
The user needs address all relevant stakeholders.
The user needs take all relevant use scenarios of the intended use into account.
The user needs cover all relevant categories (e.g. technical, regulatory, organizational, market).
The user needs are not ambiguous, self-contradicting or conflicting with each other.
The user needs are traceable.
The user needs are testable (if required).

3. Comments

4. Result

[ ] User needs passed\
[ ] User needs not passed\
[ ] User needs passed with the following obligations: <Insert if applicable>\

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Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.

More about me