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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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Detalhes bibliográficos
Publicado no:JMIR Mhealth Uhealth
Main Authors: Keutzer, Lina, Simonsson, Ulrika SH
Formato: Artigo
Idioma:Inglês
Publicado em: JMIR Publications 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7381013/
https://ncbi.nlm.nih.gov/pubmed/32589154
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2196/17567
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