
Understanding EUDAMED and Its Impact on Medical Device Compliance
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.
In the highly regulated world of medical devices and in vitro diagnostics (IVDs), ensuring compliance with international standards is critical for market access and patient safety.
The European Commission’s Health Technology Assessment Regulation (HTAR) marks a significant step toward harmonizing health technology evaluations across EU member states.
This article provides key insights to navigating China’s complex medical device regulatory landscape.
This article provides key insights to navigating China’s complex medical device regulatory landscape.
This article outlines the key steps and practices to ensure effective cybersecurity protocols.