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 […]
Internal audits – an opportunity to improve Medical Devices
Internal audits are an important activity for medical device manufacturers. It is not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. At GBA Key2Compliance, our experienced auditors support clients throughout the entire internal audit process – ensuring compliance, […]
Is Your Innovation a Medical Device?
Demystifying Regulatory Pathways for Entrepreneurs Zahra Mavajian Regulatory affairs and Quality assurance consultant – GBA Key2Compliance Are you an entrepreneur with great ideas to impact your field, whether through a new device, software, service, or system? If so, you might be wondering: Does my innovation fall under Medical Device Regulation? And more importantly, what happens […]
Developing Medical Device Software: Essential Insights for Founders
Claudia Dannehl Senior consultant, Medical Device RA – GBA Key2Compliance Many software development companies fear the classification of their software as a medical device, because developing a medical device means following many regulations. However, there are also few advantages to having software applications that qualify as medical device software (MDSW). In this blog post, we […]