April 22, 2025Our Tuttlingen branch has a new home: as of this week, we can be found in the Drei-Kronen-Hof in the…- April 16, 2025At our February information sessions on the transition from the IVDD to the IVDR, we had in-depth discussions about common…
- February 28, 2025As you are no doubt already aware, an amendment to DIN EN ISO 9001 has been published. The reason for…
- October 1, 20241st October 2024 marks the transition to operations for European Reference Laboratories (EURLs) for Class D in vitro diagnostic (IVD)…
July 9, 2024The adaptation of the transitional periods for the IVDR, published by the EU Commission in the form of Regulation (EU)…- June 24, 2024The Basic UDI-DI is an important key in product documentation (e.g. certificates, technical documentation, vigilance notifications and PSUR, SS(C)P, etc.)…
- June 3, 2024At present, there is no need to request a current declaration of conformity, if there are no changes, in addition…
- June 3, 2024At present, there is no need to request a current declaration of conformity, if there are no changes, in addition…
- January 2, 2024Reminder for the necessity of the submission of Periodic Safety Update Reports. With a certain frequency manufacturers of medical devices…
- December 7, 2023The first reference laboratories were designated with Implementing Regulation (EU) 2023/2713: 1. EU reference laboratories for devices intended for detection…
