# #383: What Standards Apply to My Device?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-09-19
- Length: 51m
- Episode: 383
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-19-383-what-standards-apply-to-my-device
- Listen: https://podcast.greenlight.guru/episode/383-what-standards-apply-to-my-device

## Summary

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.

## Outline

1. Introduction: Leo Eisner and the IEC 60601 Award
2. Why Standards are Crucial Design Inputs
3. Identifying Applicable Standards and Markets
4. Prioritizing Standards and Managing Design Risk
5. Tools for Tracking Standards and Regulations
6. Final Advice: Early Research and Expert Help

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

companies scaling up

## Mentioned

- Greenlight Guru (company)
- Eisner Safety Consultants (company)
- IEC 60601 (other)
- ISO 15223 (other)
- Underwriters Labs (company)
- MedBoard (tool)
- ANSI (company)
- Techstreet (company)
- Accuris (company)
- Intertech Inform (company)
- FDA (company)
- ISO (company)
- IEC (company)

## Related episodes from other shows

- [148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti) (Let's Combinate)
- [132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm) (Let's Combinate)
- [003 - “Standard Understanding” with Mark Swanson](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson) (Let's Combinate)
- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)

## Citing this page

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