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ISO 13485 - Quality Management System for Medical Devices accommodate norms for safe manufacturing to distribution of medical devices. The primary objective of the standard is to maintain harmony between the legal requirements and the management system. It is obligatory to accomplish ISO 13485 certification for companies exporting medical devices to other countries. benefits of ISO 13485 Standard are given as follow- Meets the global standard in implementing quality system standard Creates a systematic framework for monitoring and analyzing customer feedback Gives a reputed name in the market Reduction in costs Opens door for the intern.