Laser Marking vs. CNC Engraving for Medical Traceability: Technical, Regulatory & Biocompatibility Comparison
Global medical device regulators including FDA, EU MDR and Australia TGA enforce strict permanent traceability rules for reusable surgical instruments and implantable hardware. Under 21 CFR 801.45 and Annex VI of EU MDR, direct part marking (DPM) must remain machine-readable … 阅读更多