As the In Vitro Diagnostic Medical Device Regulation (IVDR) comes into effect, IVD manufacturers face a significant challenge in ensuring compliance with the new, stricter regulatory requirements. CAICO Medical is a leading Contract Research Organization (CRO) specializing in IVD development and regulatory support, dedicated to helping manufacturers successfully navigate the IVDD to IVDR transition.

CAICO Medical offers a comprehensive suite of services to facilitate the smooth transition of IVD (In Vitro Diagnostic) manufacturers from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR). Our services encompass a thorough Gap Analysis to identify disparities between existing IVDD documentation and IVDR requirements, ISO 13485 Quality Management System (QMS) audits for compliance evaluation, development of Performance Evaluation Plans (PEP) outlining clinical