All posts written by Margherita Fort
Margherita Fort
Regulatory Affairs Manager Graduated in Pharmaceutical Chemistry and Technology, she completed a specialization course in Regulatory Affairs and served as a Regulatory Affairs Specialist at a company manufacturing substance-based medical devices. She now holds the position of Regulatory Affairs Manager, providing support to manufacturers, importers, and distributors of medical devices and in vitro diagnostic devices.
According to the MDR Regulation, the technical documentation must be complete, well-structured, and contain sufficient information to demonstrate that the…
The Procedure Pack File for medical device systems and procedure packs, as well as the Technical Documentation for IVD kits,…