Certified for innovations in diagnostics
The requirements for proving their benefits are also increasing for in vitro diagnostics (IVD) — such as new tumor markers or tests to detect SARS-CoV2. REGULATION (EU) 2017/746 on in vitro diagnostic medical devices (IVD) will soon apply. This also tightens the requirements for performance studies, i.e. clinical studies, which must demonstrate the basic safety and performance requirements.
Just in time for Easter, we at TÜV Süd refreshed our knowledge of in vitro diagnostics and got certified. We are ready for the new requirements!
We wish everyone a happy Easter and good health to all our loved ones for the coming months.
Demonstrate the medical benefits of your product
With our many years of experience and expertise, we offer effective solutions to show the medical benefits of your product.
From conception to implementation of preclinical and clinical studies, we support you with tailor-made services.
Find out how MEDIACC can help you get your products refunded.