Production Quality Management Standards for Independent Software of Medical Device

On July 12, NMPA released Appendix to Quality Management Standards for Medical Device Production – Independent Software. Appendix is a special requirement production quality management standard for independent software of medical device, which has been in effect since July 1, 2020. The quality management system for the production of independent software medical devices shall conform to the requirements of the Standards for the Quality Management of Medical Device Production and this Appendix. The appendix follows the basic principles and general requirements of software life cycle process and network security. Independent software refers to the software that has one or moreRead More →

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