Medical Devices
Mastering regulatory change management is crucial for medical device companies to stay compliant and competitive in a rapidly evolving regulatory environment.
Medical Devices
The General Safety and Performance Requirements (GSPR) are a crucial component of the European Union’s regulatory framework for medical devices and in-vitro diagnostic devices, specifically under the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).
Medical Devices
Post-market surveillance (PMS) is a critical component of the European Union Medical Device Regulation (MDR).
Medical Devices
Clinical evaluation is the cornerstone of the European Union Medical Device Regulation (MDR).
Medical Devices
The introduction of the European Union Medical Device Regulation (MDR) represents one of the most significant changes in the history of medical device regulation in Europe.
