Digital Health & AI
87 articles
EU AI Act for Medical Devices: Compliance Guide for MedTech (2026)
Learn how the EU AI Act applies to AI-enabled medical devices, including high-risk classification, MDR/IVDR overlap, conformity assessment, and 2026 deadlines.
Real-World Evidence for Medical Devices: FDA RWE Guidance and Regulatory Uses
Guide to using real-world evidence and real-world data in medical device submissions, including FDA guidance, data sources, reliability criteria, and regulatory strategy.
Germany Medical Device Registration and Market Access Guide 2026
Market medical devices in Germany with EU MDR, BfArM, PEI, MPDG, EUDAMED, DMIDS, German labeling, clinical investigations, and DiGA strategy.
AI/ML Medical Devices: FDA Framework, SaMD Classification, Approval Paths
Guide to AI and machine learning medical device regulation, covering FDA AI/ML policy, PCCPs, SaMD classification, 510(k), De Novo, EU MDR, and Good Machine Learning Practice.
Medical Device Cybersecurity: FDA Requirements, SBOM and Compliance Guide
Learn FDA Section 524B cybersecurity expectations for medical devices, including SBOMs, threat modeling, premarket evidence, vulnerability management, and EU MDR alignment.
Software as a Medical Device (SaMD): The Complete Regulatory Guide
Guide to SaMD regulation covering IMDRF classification, FDA and EU MDR pathways, IEC 62304, IEC 82304-1, AI/ML change control, cybersecurity, and global frameworks.
IEC 62304 Medical Device Software Lifecycle: The Complete Implementation Guide
How to implement IEC 62304 for medical device software development — safety classification, lifecycle processes, SOUP management, documentation requirements, and practical tips for agile teams.