Facing the new IVD Regulation 2017/746: Contract Research Organizations (CROs), key partners of IVDs manufacturers for compliance

Clin Chem Lab Med. 2024 Apr 12;62(9):e206-e208. doi: 10.1515/cclm-2024-0389. Print 2024 Aug 27.

Authors

Sabrina Kali¹, Chloé Puisney¹, Marie-Laure Delalande¹, Guillaume Franc¹, Christiane Buisson¹, Sébastien Barradeau¹

Affiliation

¹ Cerba Xpert, ZA les Epineaux, Frépillon, France.

PMID: 38602283
DOI: 10.1515/cclm-2024-0389

No abstract available

Keywords: European regulation; IVDR compliance; analytical performance; clinical performance.

Publication types

Letter