New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference
New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in […]
Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for […]