ISO 13485 Standard includes the requirements for the implementation of a Quality Management System for medical devices. The structure of the Standard and the requirements are similar to those of international Quality Standard ISO 9001. Their main...
The organizations that are involved in the manufacturing and handling of medical devices are required to adhere to the norms of ISO 13485 standard. ISO 13485 is a set of standards that helps in the implementation of the Quality Management System for Medical Devices (MD-QMS)....
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