Nanna Finne

Since Brexit, UKCA has replaced CE marking as the route to market in Great Britain. But what that means for medical devices keeps evolving. For manufacturers, quality managers, and regulatory affairs specialists, keeping pace with these changes isn’t...

In the medical device industry, quality management isn’t just about efficiency or customer satisfaction — it’s about patient safety. That’s why having a strong ISO 13485 QMS matters so much.

Ah, design verification—the unsung hero of medical device development. It’s the phase where we ask, “Did we build this thing right?” before moving on to validation, which asks, “Did we build the right thing?”

In today’s fast-paced and tightly regulated medical device industry, a Quality Management System (QMS) is far more than a mere compliance exercise, especially for medical device manufacturers. In this article, we will tell you the ins and outs of QMS...

The prime directive of medical device manufacturers is the continued safety of patients through safe and effective medical devices. A critical aspect of medical device safety is ensuring regulatory compliance of any medical device destined for the co...

As of February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) is officially in force. The FDA’s new Quality Management System Regulation (QMSR) represents the most significant overhaul of U.S. medical device quality requirements in mo...

Any medical device manufacturer developing new products comes across design verification and validation. They are essential stages during the design control of a new medical device. Design controls are a series of steps and processes during the devel...

A fundamental part of safeguarding patients in Europe comes from ensuring that medical devices and in vitro diagnostics (IVDs) meet consistent, high regulatory standards. Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation...

The EU medical device regulatory framework continues to evolve. As EUDAMED modules roll out and MDR timelines shift, many manufacturers are finding that maintaining compliance now requires far more structure and oversight than it did just a few years...

Staying ahead of industry shifts has never been more critical for anyone working in biotech, pharma, or MedTech. The pace of innovation is accelerating, regulatory expectations are tightening, and AI is reshaping everything from discovery to commerci...