The latest writings from our team

This post explores the challenges of managing redundant information in technical documentation for the In Vitro Diagnostic Regulation (IVDR) It highlights the potential pitfalls, document management issues, and the need for a more efficient approach. The post introduces meddevo as a solution to revolutionize and streamline product information management, ultimately enhancing regulatory compliance.

The In Vitro Diagnostic Regulation (IVDR) has introduced a new era for IVD manufacturers, introducing a risk-based classification system that is fundamentally different from its predecessor, the IVDD. This shift from list-based categorization to risk classes is a significant change, and understanding these classes is critical for compliance.