Insights

Medical Devices

Blog post29 October 2025

MDR made simple: Why technical documentation is the backbone of MDR compliance

If device classification is the diagnosis, then technical documentation is the treatment plan.

Medical Devices

Blog post22 October 2025

IVDR: Navigating supply chain challenges with confidence

The EU In Vitro Diagnostic Regulation (IVDR) is reshaping the IVD landscape, placing new and far-reaching demands not only on manufacturers but also on distributors, importers, and authorized represen...

Medical Devices

Blog post16 October 2025

MDR made simple: Why device classification shapes everything that follows

The EU Medical Device Regulation (MDR) sets a high standard for demonstrating the safety, performance, and compliance of medical devices. To support manufacturers in meeting these requirements, DNV la...

Medical Devices

Blog post19 May 2025

Digitalizing IVDR compliance: Empowering medical device manufacturers for EU market success

Discover how digital solutions streamline IVDR certification, reduce regulatory burdens, and accelerate market entry for in vitro diagnostic (IVD) manufacturers.