Medical-scientific committee and DSMB: two key bodies for ensuring the safe clinical development of a medical device. Roles, composition, and regulatory issues.
The essential role of medical-scientific committees and other committees of interest Read more »
The PSUR medical device: regulatory requirement MDR 2017/745 for Class IIa, IIb, and III MDs. Content, frequency, and challenges for manufacturers.
The PSUR: a complex puzzle with multiple dimensions Read more »
The digitization of clinical trials is advancing in France: pilot phase open for 20 projects. Dematerialization, rSDV, decentralized trials—regulatory framework and opportunities for sponsors.
Digitization of clinical trials in France: the window is open! Read more »
