All posts written by Sara Simoncioni
Sara Simoncioni
Regulatory Affairs Executive
Laureata in Medical Biotechnologies, ha ricoperto i ruoli di R&D Associate e Regulatory Affairs Specialist presso un’azienda fabbricante di dispositivi medici a base di sostanze. Ora ricopre il ruolo di Regulatory Affairs Executive, fornendo consulenza e supporto pratico nella redazione di documenti a fabbricanti e altri attori che operano nel settore dei dispositivi medici.
Biological evaluation is a crucial aspect of medical device development. It should first be addressed during the design verification phase…
The Medical Devices Regulation (EU) 2017/745 (MDR), which came into effect in 2017 to replace the directives (93/42/EEC on medical…
The first step in preparing the TD is to create a Technical Documentation template that allows for the inclusion of…
For all medical devices except custom-made devices, manufacturers are required to draft and maintain up-to-date Technical Documentation in accordance with…
The introduction of reporting requirements for post-market surveillance (PMS) by the MDR necessitates a more coherent, standardized, and systematic review…
