AI in Medical Devices: Understanding the Review Process and Common Gaps
Free webinar with BSI and GBA Key2Compliance As artificial intelligence becomes increasingly integrated into medical devices, manufacturers face new challenges in demonstrating regulatory compliance. Understanding how AI is assessed, what notified bodies look for, and where common gaps arise is important when preparing for regulatory assessment. Join GBA Key2Compliance and BSI for a free webinar where […]
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 […]
QA/RA Perspectives: Nadia Ragnvald Caspersen
A clear strategy starts with deciding what your first product needs to do For medical device and IVD companies, the path to market can become more complicated long before a submission is prepared. Decisions about product features, intended purpose and claims can all affect the regulatory and clinical work that follows. For Nadia Ragnvald Caspersen, […]
Beyond compliance in Bologna: sharing knowledge across borders
On 30 September and 1 October, GBA Key2Compliance colleagues Emily Malmberg and Maria Nordlinder travelled to Bologna to participate as invited speakers at Complife’s annual MDG Health Matters – Medical Device Governance Forum: Beyond Compliance. Complife, part of GBA Group, brought together representatives from across the medical device and IVD industry, including the Italian Ministry […]
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) […]
QA/RA Perspectives: Lars Mentzer
Quality assurance and regulatory compliance are not something you can buy out of the box For medical device and IVD companies, bringing a product to market involves much more than meeting a list of regulatory requirements. It requires an understanding of why those requirements exist, how quality supports the organization and, ultimately, how it contributes […]
Free webinar: Quality Risk Management & Root Cause Investigations
22 October 2026 | 15:00 Swedish time | Online How do you get beyond assumptions when investigating a problem or assessing a risk? Join James Vesper, one of our expert course instructors, for a free introduction to our upcoming three-day workshop for the pharmaceutical and medical device industries. He’ll explore how investigations look backwards while […]
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 […]
Biological Safety Support throughout the Medical Device Lifecycle
Is your Biological Evaluation Documentation ready for the latest ISO 10993 expectations? Biological safety is not a one-time regulatory activity. Throughout the medical device lifecycle, manufacturers must continually assess whether existing biological safety evidence remains sufficient as standards evolve and devices, materials, suppliers, and processes change. Regulatory expectations continue to evolve throughout the medical device […]
Welcome Gunilla Landin, our new Senior QA/RA Consultant
Gunilla Landin has recently joined GBA Key2Compliance as our new Senior QA/RA Consultant. With extensive experience in regulatory affairs across both pharmaceuticals and medical devices, Gunilla brings valuable knowledge and a broad perspective to our team. Gunilla is a pharmacist by training and has worked within regulatory affairs for most of her professional career. She […]