Medical Devices
Packaging validation is a critical component of ensuring the safety, sterility, and integrity of medical devices.
EU
The new article provides clarifications regarding the transitional arrangements associated with the changes in the legal framework.
Medical Devices
Mastering regulatory change management is crucial for medical device companies to stay compliant and competitive in a rapidly evolving regulatory environment.
EU
The article describes in detail the approach to be followed in order to determine the regulatory status and applicable regulatory requirements.
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).
