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April 26, 2026
CE Marking for Surgical Instruments in 2026: Complete EU MDR Guide for Distributors
EU MDR 2017/745 has significantly reformed CE marking requirements for surgical instruments since 2021. This guide covers device classification, required techni…
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Compliance
April 26, 2026
ISO 13485 vs ISO 9001 for Surgical Instruments: What Distributors Must Know
ISO 13485 and ISO 9001 are both quality management standards, but only one is specifically written for medical device manufacturers. This guide explains the dif…
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