To demonstrate the commitment to the quality of medical devices
ISO 13485 is an internationally recognized standard for demonstrating the quality in the medical device industry. It is mainly designed for organizations for the development, designing, production, servicing and sales of medical devices.
What is ISO 13485
The main objective of ISO 13485 is, to facilitate the coordination with regulatory requirements of medical devices. It is standalone standard mainly for expressing the commitment of the quality of medical devices. Its structure is based on ISO 9001, it includes requirements like analysis of risk, traceability, and manufacturing of sterile. ISO 13485 certified organizations cannot claim conformity to ISO 9001.
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