Topic
Biocompatibility
4 articles
Biocompatibility
NAMs for Medical Device Biocompatibility: FDA, EU & ISO 10993 Guide (2026)
NAMs for medical device biocompatibility: FDA roadmap, EU phase-out plan, ISO 10993-5/-10/-23 in vitro alternatives, chemical characterization, and regulatory strategy.
24 min read2026-06-02
›Standards & Testing
ISO 17025 Test Laboratory Selection for Medical Devices: Complete Guide
Guide to selecting ISO 17025 accredited laboratories for medical device biocompatibility, EMC, safety, and sterilization testing, including FDA ASCA scope checks and cost factors.
18 min read2026-04-25
›Biocompatibility
ISO 10993-1:2025: What Changed, Why It Matters, and How to Prepare
Practical guide to ISO 10993-1:2025 changes, including risk-based biological evaluation, the new table framework, exposure duration updates, genotoxicity, and compliance steps.
19 min read2026-04-02
›Biocompatibility
ISO 10993 Biocompatibility Testing for Medical Devices: The Complete Guide
A comprehensive guide to biological evaluation and biocompatibility testing under ISO 10993 — from categorization and test selection to chemical characterization and FDA expectations.
76 min read2026-03-19
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