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, […]