The qualifications of the quality manager of a medical device factory should not only meet the requirements of ISO13485, but also comply with the requirements of the production license of the medical device manufacturer.
Because the medical device manufacturer belongs to the front-end license approval industry, so it must be in accordance with the relevant production license management approach to the implementation of the current prescriptive requirements for the medical device plant quality officer must be a related professional (biology, medicine, chemical industry, etc.) specialist or above, and after graduation have 5 years of work experience can be!