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Are you developing a medical device? Would you like to bring your device to the market? Then you do need a Quality Management System. There are parts of the FDA regulations and ISO requirements that do apply to you, even if you are pre-market.
In this webinar we will discuss:
Which are the requirements of the Medical Device Regulation? What is the role of Quality Management System? What are the building blocks of the Quality management system? What are the different stages of Quality Management System ? How different elements of Quality Management System can be integrated/bootstrap together? Role of Usability engineering in the Quality Management System? A demonstration of the Quality Management System Software (eQMS working examples)