https://blog.ing-engel.org/en/blog/ Engineering services (RA & AI) en https://blog.ing-engel.org/en/blog/ai-act-medical-devices-2028/https://blog.ing-engel.org/en/blog/ai-act-medical-devices-2028/Fri, 02 Oct 2026 00:00:00 GMTThe Digital Omnibus pushes the high-risk obligations for AI in medical devices back by a year. Notified bodies warn of a bottleneck. https://blog.ing-engel.org/en/blog/ai-in-ra-work-source-grounding/https://blog.ing-engel.org/en/blog/ai-in-ra-work-source-grounding/Fri, 02 Oct 2026 00:00:00 GMTTwo research papers show how AI can support safety documentation and classification without sacrificing traceability. Still at concept stage, but a useful principle. https://blog.ing-engel.org/en/blog/fda-generative-ai-devices-discussion-paper/https://blog.ing-engel.org/en/blog/fda-generative-ai-devices-discussion-paper/Fri, 02 Oct 2026 00:00:00 GMTFDA outlines a competency-based assessment for medical devices that use generative AI. Not a requirement yet, but a clear signal of what manufacturers should prepare for. https://blog.ing-engel.org/en/blog/fda-radiology-ai-510k/https://blog.ing-engel.org/en/blog/fda-radiology-ai-510k/Fri, 02 Oct 2026 00:00:00 GMTFDA has denied a partial exemption for radiology CAD and triage software. What manufacturers should now build into their submission planning. https://blog.ing-engel.org/en/blog/standards-ai-qms-risk-management/https://blog.ing-engel.org/en/blog/standards-ai-qms-risk-management/Fri, 02 Oct 2026 00:00:00 GMTA European QMS standard for the AI Act and an ISO guide to risk management for machine learning. What they cover and where the gap remains.