Medical Devices
Packaging validation is a critical component of ensuring the safety, sterility, and integrity of medical devices.
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).
