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In-depth articles on biological evaluation, EU MDR, FDA biocompatibility, and medical device regulatory strategy — written by a practising ISO 10993 consultant.

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ISO 10993

ISO 10993-1:2025 — The Lifecycle Approach Changes Everything

The 2025 revision of ISO 10993-1 is not just a terminology update. It fundamentally reframes how biological safety must be evaluated across the entire device lifecycle — and many existing BEPs have gaps that need addressing now.

Arvind Rathore Arvind Rathore · Mar 10, 2025 · 7 min read
Lifecycle approach across raw materials → clinical use
Explicit benefit-risk determination required
Test waivers encouraged with rigorous justification
Stronger link to chemical characterization & TRA
Showing 9 of 12 articles

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