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ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system (QMS) specifically designed for the medical device industry. It applies to organizations involved in the design, development, production, installation, and servicing of medical devices, as well as suppliers and external parties that provide related services. Achieving ISO 13485 certification demonstrates a company’s commitment to product safety, regulatory compliance, and consistent quality across all stages of the medical device lifecycle.

Understanding ISO 13485

ISO 13485 focuses on establishing a structured and documented quality management system that

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