In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).

Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide.

Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices.

The newly proposed MDCG guidelines are a valuable resource for manufacturers (of products without an intended medical purpose), notified bodies, and stakeholders navigating the intricate landscape of medical device regulatory standards.