Insights

Medical Devices

Blog post16 March 2026

EUDAMED mandatory use: What manufacturers need to know

EUDAMED is the European Database on Medical Devices. It is the central IT system used by the European Commission, Competent Authorities, manufacturers, and Notified Bodies to share regulatory informat...

Medical Devices

26 January 2026

Powering trust in medical technology: Why certification matters more than ever

Healthcare today is powered by technology. But when lives depend on that technology, an important question remains: who powers trust? And what does responsibility really look like in a world where inn...

Medical Devices

Blog post14 January 2026

MDR Made Simple: Why an MDR-ready QMS is the operating system behind compliance

Understanding where MDR obligations sit within your Quality Management System (QMS) and how to control them.

Medical Devices

Blog post14 January 2026

MDR made simple: Why clinical evaluation keeps MDR compliance alive after CE marking

How clinical evidence and post-market data work together to demonstrate safety and performance throughout the device lifecycle.

Medical Devices

Blog post18 December 2025

IVDR classification: Why so many devices are being misclassified and why the risk is bigger than you think

As the IVDR transition continues, one issue keeps coming up during Notified Body reviews: Devices are being misclassified.

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

Medical Device Regulation 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.