Global medical devices firms that market in-vitro diagnostic (IVD) products in the European Union must comply with the new IVD Regulations that came into effect in 2017. The new regulations place additional focus on clinical evidence, post-market surveillance, and device traceability. Non-compliance with the regulations by the 2022 deadline can threaten the top-line of medical device manufacturers. Cyient offers multiple workstreams including regulatory, quality, engineering, clinical evidence, labeling, and EUDAMED submission, to support your IVDD to IVDR transition.
Download the brochure and discover how you can leverage our domain knowledge, regulatory expertise, and functional capabilities to accelerate your EU IVDR compliance by the May 2022 deadline.