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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...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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JMIR Publications
2020
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381013/ https://www.ncbi.nlm.nih.gov/pubmed/32589154 http://dx.doi.org/10.2196/17567 |