# How to Leverage IEC 62304 to Improve SaMD Development Processes

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-03-18
- Length: 37m
- Episode: 137
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes
- Listen: https://podcast.greenlight.guru/episode/how-to-leverage-iec-62304-to-improve-samd-development-processes

## Summary

Cathy Wilburn, Director of Quality Assurance and Compliance at The RND Group, explains how to leverage the IEC 62304 standard for Software as a Medical Device (SaMD) development. She clarifies that IEC 62304 is a voluntary, recognized consensus standard that provides a framework for software lifecycle processes rather than a prescriptive waterfall methodology, allowing for agile integration. The discussion covers mapping these processes to FDA 21 CFR 820.30 design controls, using software safety classes (A, B, C) for risk management per ISO 14971, and navigating regulatory submissions for both the US (510(k)/PMA) and EU (MDR/IVDR).

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes#t=0) Introduction: Cathy Wilburn and The RND Group
- [3:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes#t=235) IEC 62304 as a Voluntary Framework
- [8:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes#t=501) Blending Agile and Waterfall Methodologies
- [18:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes#t=1094) Design Controls and Risk Management
- [29:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes#t=1773) EU MDR Impact on Software Classification

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- The RND Group (company)
- IEC 62304 (other)
- Green Light Guru (company)
- FDA (other)
- ISO 14971 (other)
- EU MDR (other)
- TIR 45 (other)

## Related episodes from other shows

- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (Let's Combinate)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [Living Documentation and Test Automation with Paul Massey](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-15-living-documentation-and-test-automation-with-paul-massey) (The Pragmatic Embedded Podcast)
- [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)
- [170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-08-170-the-1-secret-to-understanding-iso-13485-youll-wish-you-knew-sooner) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-18-how-to-leverage-iec-62304-to-improve-samd-development-processes. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.