Considered as one of the most highly regulated sector in the world, the medical devices industry must demonstrate compliance with regulatory and product requirements to ensure safety and performance of medical devices produced.
ISO 13485:2016 Medical Device Management Systems (MDMS) is the international standard that sets out the requirements for Quality Management System standard specifically for the medical devices industry. It encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements. It is designed to be used by organisations throughout the lifecycle of a medical device and it also covers storage, distribution, installation and servicing, and the provision of associated services.
The training courses will provide the knowledge and understanding of the requirements of ISO 13485:2016 to help organisations increase their competitive advantage in the medical device industry.
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