The latest issue of the Journal of Medical Device Regulation
November 2026 – Volume 23, Issue 4
Snapshot of the November 2026 issue of the Journal of Medical Device Regulation:
- Quality: A risk-centric framework for simultaneous compliance with the US QMSR, EU MDR, and MDSAP
- SaMD/DTx: Inconsistencies in terminology for SaMD and DTx in regulatory frameworks
- Indonesia: A regulatory gap analysis of ISO 14155:2026 and Indonesia’s Permenkes 63/2017 on clinical investigations to support harmonisation
- WET: Reconceptualising ‘well-established technology’ in the EU’s Regulation on medical devices
- Networked devices: Addressing system-level risk management in networked healthcare technologies
- AI in QMSs: An MLOps framework for AI-integrated Quality Management Systems
- Meeting report: RAPS Convergence 2026 – adapting regulation for the next 50 years
- Medical device and IVD regulatory news updates from Argentina, Botswana, Brazil, Canada, China, Czech Republic, Egypt, EU, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Japan, Malaysia, Mexico, Norway, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Thailand, Uganda, UK, United Arab Emirates, and the USA
