All posts written by Sara Simoncioni
Sara Simoncioni
Regulatory Affairs Executive
Graduated in Medical Biotechnologies, she has held positions as R&D Associate and Regulatory Affairs Specialist at a company manufacturing substance-based medical devices. She currently serves as Regulatory Affairs Executive, providing consulting and practical support in the preparation of documents for manufacturers and other stakeholders in the medical device sector.
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…
