Hardware Podcasts

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

Global Medical Device Podcast · 8 Dec 2025 · 43m · Episode 436

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Simply Medica, AWS, Microsoft, FDA, Greenlight Guru, NHS
Tools
GitHub, GitLab
Also
ISO 13485, IEC 62304, GAMP, HIPAA, GDPR

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