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. The world of in vitro diagnostics is all about accuracy and reliability.

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.

On 14th December 2023, the Medical Device Coordination Group (MDCG) has released two new documents: MDCG 2023-5 & MDCG 2023-6