# 170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-01-08
- Length: 9m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-08-170-the-1-secret-to-understanding-iso-13485-youll-wish-you-knew-sooner
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/170---The-1-Secret-to-Understanding-ISO-13485-Youll-Wish-You-Knew-Sooner-e2t58dc

## Summary

Subhi Saadeh, host of Let's Combinate and Quality Professional, explains how viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles simplifies implementation for medical device and combination product companies. He contrasts the standard's framework approach with mandatory regulations like 21 CFR 820, demonstrating how each clause from QMS (Clause 4) to Design and Development maps to specific PDCA stages. Saadeh argues that this perspective shifts ISO 13485 from a static rule book to a dynamic guide for continuous improvement and real-world process effectiveness.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-08-170-the-1-secret-to-understanding-iso-13485-youll-wish-you-knew-sooner#t=0) Introduction: Subhi Saadeh and the PDCA Insight

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- ISO 13485 (other)
- 21 CFR 820 (other)
- MDSAP (other)

## Related episodes from other shows

- [Meet a Guru: Karen Schuyler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler) (Global Medical Device Podcast)
- [#371: Achieving ISO 13485 Certification](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-28-371-achieving-iso-13485-certification) (Global Medical Device Podcast)
- [Meet a Guru: Taylor Brown](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-01-meet-a-guru-taylor-brown) (Global Medical Device Podcast)
- [Meet a Guru: Maryann Mitchell](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell) (Global Medical Device Podcast)
- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-08-170-the-1-secret-to-understanding-iso-13485-youll-wish-you-knew-sooner. 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 Let's Combinate.