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In the highly regulated and safety-critical field of medical device manufacturing, adherence to stringent quality management systems is imperative. One such globally recognized standard that governs the quality management system for medical devices is ISO 13485. Attaining ISO 13485 certification is not just a badge of compliance; it is a commitment to maintaining the highest standards in the design, development, production, and distribution of medical devices.ISO 13485 is an international standard that sets out the requirements for a... more