We support our clients to achieve conformity for their “in vitro diagnostic medical devices” (IVD) according to the IVD Regulation (EU) 2017/746 by
- developing the right strategies for the IVD
- getting prepared for IVDR conformity, and
- perform activities for performance evaluation and clinical evidence covering the three pillars scientific validity, analytical performance, and clinical performance for the device before (reference: IVDR Chapter VI “Clinical evidence, performance evaluation and performance studies) and after market entry (reference: IVDR Chapter VII “Post-market surveillance, vigilance and market surveillance) in compliance to the IVDR