Biocompatibility
6 articles
Medical Cyanoacrylate Tissue Adhesive Sourcing & Regulatory Guide
A technical sourcing guide for medical cyanoacrylate tissue adhesives: intended use classification, 2-octyl vs n-butyl chemistry, ISO 10993, and lot release.
Philips CPAP Recall: PE-PUR Foam, 15 Million Devices, 561 Deaths Teardown
A detailed regulatory and quality system teardown of the Philips Respironics CPAP recall. Understand PE-PUR foam chemistry, the FDA consent decree, and MDR metrics.
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.
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.
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.
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.