Quality that works beyond the audit: GBA Key2Compliance granted ISO 9001 recertification
A quality management system should support everyday decisions, clear processes and continuous improvement, not just preparation for the next audit. For organisations developing or maintaining their QMS, the question is how to make quality work in practice. At GBA Key2Compliance, this is a principle we apply both in our own operations and in our support […]
Beyond Prompt Engineering: How LLMs Can Be Effective in a Regulatory Context
Webinar | 20 January 2027 | 09:00–09:45 CET Hosted by GBA Key2Compliance and Johner Institute, both part of GBA MedTech Solutions, in collaboration with Swedish Medtech. The problem: A language model only knows what you show it. Without context, it provides answers that sound plausible but are generic or incorrect. In this webinar, you’ll learn […]
UK confirms indefinite recognition of CE-marked medical devices – What manufacturers need to know
The UK government has confirmed plans to recognise CE-marked medical devices and in vitro diagnostic devices (IVDs) indefinitely in Great Britain. The decision provides greater regulatory certainty for manufacturers and supports continued access to medical technologies for patients and healthcare providers. On 21 October 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the […]
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 […]