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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-08-07
- Length: 26m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/148---Standards-Applicability-Assessments--Atomic-Requirements--Documentation-and-Timing-with-Leo-Eisner-e2mre95

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti#t=0) Introduction: Subi Saadeh and Leo Eisner
- [2:32](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti#t=152) Assessing Standards Applicability: Product Environment and Markets
- [7:08](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti#t=428) Documenting Standards Assessments and Atomic Requirements
- [11:20](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti#t=680) Timing, Stage Gates, and Stakeholder Responsibilities
- [20:38](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti#t=1238) Final Thoughts: Resources and Common Pitfalls

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Eisner Safety Consultants (company)
- IEC 60601 (other)
- ISO 15223 (other)
- ISO 20417 (other)
- ISO 15747 (other)
- FDA (other)
- MDR (other)
- CB Scheme (other)

## Related episodes from other shows

- [#383: What Standards Apply to My Device?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-19-383-what-standards-apply-to-my-device) (Global Medical Device Podcast)
- [#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-12-12-395-iec-60601-updates-what-medtech-professionals-need-to-know-for-2025-and-beyon) (Global Medical Device Podcast)
- [Meet a Guru: Brittani Smith](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith) (Global Medical Device Podcast)
- [#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu) (Global Medical Device Podcast)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)

## Citing this page

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