ISO 9001:2026 Is Here: What Does It Mean for Medical Device Companies Using ISO 13485?
The publication of ISO 9001:2026 raises important questions for companies across the medical device supply chain. What does the new edition mean for organisations working according to ISO 13485, and which companies actually need to take action? In this article, we explain where the two standards differ and what medical device companies, suppliers and dual-certified […]
EUDAMED registration: Are you ready for the 28 November 2026 deadline?
The next important EUDAMED deadline is approaching. By 28 November 2026, manufacturers must ensure that applicable legacy devices and other devices covered by the transitional registration requirements are registered in EUDAMED. Is your organisation prepared? Since 28 May 2026, the use of four EUDAMED modules has become mandatory under the EU Medical Device Regulation (MDR) […]
Is your AI software a medical device? Questions every health tech startup should ask early
You have identified a problem in healthcare and built an AI solution that could help solve it. Perhaps it analyses patient information, highlights patterns or supports a healthcare professional’s decisions. As you move from prototype to product, one question deserves attention early: could your software be a medical device? For a software startup, the answer […]
A New ISO Standard for IVD Performance Evaluation Is Taking Shape
Performance evaluation is central to demonstrating conformity under the EU IVDR. To date manufacturers have typically established their performance evaluation frameworks by drawing on the Regulation, MDCG guidance and several standards addressing individual parts of the evidence lifecycle. A new ISO project, currently under development, may eventually provide a more consolidated international reference for performance […]
Own-Brand Distribution Under MDR/IVDR: Who May Assign the UDI-DI?
Anna SahlholmConsultant manager, GBA Key2Compliance When the same medical device is sold under different trade names, it may seem logical for each brand owner to obtain its own UDI-DI. Under the EU MDR and IVDR, however, the decisive question is not who owns the brand, but who acts as the legal manufacturer. MDCG 2026-5 addresses […]
When a notified body disappears: what TÜV NORD Scandinavia’s bankruptcy tells us
On 22 July 2026, TÜV NORD Scandinavia Medical Notified Body AB entered bankruptcy proceedings, shortly after being acquired from RISE. According to Bolagsverket, the Swedish notified body has now ceased operations. For manufacturers, it is a reminder that notified body capacity is not just a regulatory issue, it is also a business continuity risk. For […]
MDR Is Not Too Complex – The Importance of a Clear Clinical Strategy
Jeanette Demorney Senior Advisor, Clinical Development – GBA Key2Compliance One of the most common statements you hear in MedTech right now is that MDR is simply too complex. It is often described as bureaucratic, unpredictable, and overly demanding, particularly for small and mid-sized companies. For many, the regulation itself has become the explanation for why […]
Timing is Everything: The Crucial Role of QMS in Your Medical Device Journey
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA- GBA Key2Compliance For startups in the medical device sector, the timing of your Quality Management System (QMS) implementation can significantly influence your path to market and the submission of your technical file. While it may be tempting to focus solely on product development, integrating a QMS early […]
Quality Culture -Technology helps, but people make it work
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA – GBA Key2Compliance Picture this: You’re racing to meet a production deadline, juggling compliance requirements, and fighting to keep costs under control. Amid all that pressure, one question looms large: How do we make quality more than a tick-box exercise? Because quality isn’t just a requirement. It’s the backbone of trust, the measure of […]
Quality Risk Management, Powered by People
Nadia Ragnvald CaspersenSenior consultant, Medical Device QA/RA – GBA Key2Compliance Building better systems through respect, teamwork, and ongoing improvement Quality management isn’t just about systems and standards—it’s about people. Every device we help bring to market is ultimately used by someone who trusts it with their wellbeing. As QA/RA professionals, our responsibility goes far beyond compliance; it’s about safeguarding lives, supporting clinicians, and earning the […]