Medical Device Apps: An Introduction to Regulatory Affairs for Developers
The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must...
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JMIR Publications,
2020-06-01T00:00:00Z.
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