![]() This Standard specifies requirements for a Quality Management System (QMS) that can be used by an organisation involved in one or more stages of the life cycle of a medical device including the design & development, production, storage & distribution, installation, servicing & final decommissioning & disposal of medical devices. ![]() ![]() ISO EN 13485:2016 was published on 26th February 2016 and has now completed its transition period since April 2019. ISO EN 13485:2016 is the global harmonized Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell into Europe.
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