# #436: Do ISO 13485's Production Controls apply to SaMD?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-12-08
- Length: 43m
- Episode: 436
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd
- Listen: https://podcast.greenlight.guru/episode/436-production-controls-for-samd-navigating-iso-13485-in-a-virtual-world

## Summary

Adnan Ashfaq, founder of Simply Medica, explains how to apply ISO 13485 production controls to Software as a Medical Device (SaMD), arguing that hardware-centric clauses must be interpreted in a 'virtual manufacturing space.' He details the validation of Software of Unknown Provenance (SOUP) as purchased components, the necessity of a Software Bill of Materials (SBoM), and the integration of FDA Computer Software Assurance (CSA) guidance. The discussion covers specific ISO clauses including 7.5 (Production), 7.4 (Purchasing), 6.3/6.4 (Resources/Environment), and 7.3.8 (Design Transfer), emphasizing that agile development requires rigorous documentation to satisfy regulatory audits.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=0) Introduction and ISO 13485 Context
- [5:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=300) Clause 7.5 and the Virtual Manufacturing Space
- [5:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=300) SOUP Validation and Clause 7.4 Purchasing
- [5:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=300) FDA CSA Guidance and GAMP Frameworks
- [5:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=300) Medical Device File Requirements and SBoM
- [16:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=1014) Agile Development and Version Control Risks
- [16:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=1014) Resource Management and Contamination Control
- [22:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=1350) Design Transfer to Production and Documentation
- [35:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd#t=2146) Post-Market Surveillance and Final Advice

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)

## Most relevant to

early-stage companies

## Mentioned

- Simply Medica (company)
- ISO 13485 (other)
- IEC 62304 (other)
- GitHub (tool)
- GitLab (tool)
- AWS (company)
- Microsoft (company)
- GAMP (other)
- FDA (company)
- Greenlight Guru (company)
- NHS (company)
- HIPAA (other)
- GDPR (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)
- [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)
- [090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak) (Let's Combinate)
- [198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed) (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/2025-12-08-436-do-iso-13485s-production-controls-apply-to-samd. 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.