SaMD
23 articles
Digital Therapeutics (DTx) Regulatory Pathway Guide (2026): FDA, EU MDR, DiGA & Global Approval
A complete guide to the regulatory pathway for digital therapeutics — including FDA clearance strategies (510(k), De Novo, PMA), EU MDR classification, Germany's DiGA reimbursement program, approved DTx products, clinical evidence requirements, and what's changing in 2026.
EU AI Act for Medical Devices: Compliance Guide for MedTech (2026)
Comprehensive guide to the EU AI Act requirements for AI-enabled medical devices — covering high-risk classification, conformity assessment, the dual compliance model with MDR/IVDR, data governance, transparency, human oversight, and the August 2026 enforcement deadline.
AI/ML in Medical Devices: FDA Regulatory Framework, SaMD Classification, and Approval Pathways
The complete guide to artificial intelligence and machine learning in medical devices — FDA's AI/ML action plan, predetermined change control plans, SaMD classification, 510(k) and De Novo pathways, EU MDR requirements, and Good Machine Learning Practice.