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Key points for the implementation of the SME medical device R&D process
Abstract：With the increasingly stringent regulations on the medical device industry at home and abroad
With the increasingly stringent regulations on the medical device industry at home and abroad, the medical device industry is also facing industrial upgrading. More and more enterprises are paying attention to the compliance of the design and development process of medical device products. Whether it is ISO 13485 or FDA QSR 820, it is the same as the domestic medical device production quality management standard. It is the same in the design and development process, the design and development process is standardized, and the designed output product is safe and reliable. Looking at the design and development process of managing large companies and large enterprises, small businesses can only look down on the ocean, and there are not so many resources available! And look at Hangzhou Commitment Medical Technology Co., Ltd. Chen Xinlei Chen Zong, how to break through the design and development of medical devices from small businesses.