News

We wish our customers, colleagues, partners and other stakeholders the best of joy and cheer for Christmas and the coming year.

We are proud to announce that Future Diagnostics Solutions has now succesfully transitioned its Quality Management System to ISO 13485:2016. The scope of the approval is applicable to research, development, manufacturing, sales and distribution of in vitro diagnostic medical devices and accessories, including R&D services and contract manufacturing. Future Diagnostics is ISO 13485 certified since 2004.

Surely you have heard about it: the IVD, the new In Vitro Diagnostic Medical Devices Regulation. Published in May 2017, it replaces the In Vitro Diagnostic Medical Devices Directive (IVDD) and brings new requirements for manufacturers. The good news is: there is a five-year transition period. But do you know how this affects you, and how you will make sure you are fully compliant by 2022?

At MEDICA we organized the first IVDR & Immunoassays Mini-Symposium together with Qarad and Tüv Süd.

Future Diagnostics is proud to be part of the BIOCDx EU Project