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 innovation is moving faster than ever?

This question was central to our discussions at DNV’s recent Senior Management Council meeting in Oslo. It was an opportunity to reflect not only on how far medical technology has come, but on the critical role certification plays in ensuring that innovation remains safe, reliable, and worthy of trust.

Medical devices at the heart of modern healthcare

It all starts with the devices we rely on every day, devices that diagnose, monitor, and treat disease. From the thermometers many of us have at home, to advanced MRI scanners and increasingly sophisticated software-based diagnostics, medical devices form the backbone of modern medicine.

Over the years, advances in testing and diagnostics have transformed how we detect and manage disease. Innovations in areas such as HIV testing have dramatically improved early diagnosis, treatment outcomes, and long-term patient care. What were once complex, laboratory-based procedures are now faster, more accurate, and increasingly accessible, strengthening public health systems around the world.

In recent years, this progress has become tangible for everyone. COVID-19 testing moved diagnostics out of specialized clinical environments and into everyday life, at home and at the point of care. Alongside the rapid growth of home diagnostics, this shift made one thing very clear: reliable, well-regulated medical devices are essential to protecting individuals, families, and entire communities.

Certification as the foundation of trust

This is where certification becomes critical. Certification is the foundation of trust in medical technology. It ensures that medical devices placed on the market are safe, effective, and reliable, not just at the point of approval, but throughout their entire lifecycle.

Before a medical device can reach patients, it must undergo independent assessment of its clinical evidence, technical documentation, and quality management systems. This assessment is carried out by a Notified Body, an independent organisation authorized to evaluate compliance with regulatory requirements.

As Notified Bodies under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), DNV Product Assurance AS and DNV MEDCERT provide independent, rigorous, and transparent assessments. Expectations under these regulations have risen significantly. Clinical evidence requirements are stronger, quality systems must be more robust, and risk management is more critical than ever. Our role is not only to assess compliance, but to support manufacturers in navigating this complexity, balancing innovation with patient safety and regulatory integrity.

Growth with purpose, partnership at the core

At DNV, we believe strongly that certification is not just a technical process, it is a human one. Behind every device, every submission, and every audit are people, teams, and ultimately patients. That is why we place such high value on connecting with our customers in a personal and meaningful way: listening carefully, understanding their challenges, and adapting alongside them.

Bringing the customer voice into the conversation

At our Senior Management Council, we wanted to demonstrate this partnership rather than simply talk about it. That’s why we invited two of our medical customers to share their perspectives and experiences, what matters most to them, and what they believe is most relevant for all of us shaping the future of medical technology.

Their insights reinforced an important truth: compliance provides structure and safety, but it is through dialogue, shared understanding, and trust that true progress happens. Certification should not be seen as a box-ticking exercise or a hurdle to overcome, but as a framework that enables innovation to reach patients safely and sustainably.

Shaping the future of trusted healthcare

Our commitment is clear. We are here to build trust in medical technology and to work in partnership with manufacturers to shape the future of safe, reliable, and innovative healthcare. As medical technology continues to evolve, certification will remain a cornerstone of that trust, supporting innovation while ensuring that patient safety, performance, and reliability are never compromised.

That responsibility is one we take seriously, and one we are proud to share with our customers as long-term partners on this journey.

1/26/2026 1:46:00 PM