Hardware Podcasts

#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech

Global Medical Device Podcast · 2 Feb 2026 · 37m · Episode 445

What this episode covers

Thor Rollins, a leader at Nelson Labs and convener of the ISO committee revising ISO 10933-1, explains the 2025 standard's shift from checkbox testing to a risk-based approach aligned with ISO 14971. He details new requirements for lifecycle evaluation, particularly for reprocessed devices, and the concept of biological equivalence to reduce redundant testing. Rollins also discusses the US's rejection of the draft due to lack of guidance, the upcoming technical specifications, and practical advice for companies at different stages of development.

Most relevant to

early-stage companies, companies scaling up and established companies

Topics

Mentioned

Companies
Nelson Labs
Tools
DSC, GPC, FTIR
Also
ISO 10933-1, ISO 14971, FDA, MHRA, MDR

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