Get the latest global medical device regulatory news from our experts.
US FDA Unveils Next Steps for Regulating Artificial Intelligence-Based Medical Software
US regulators explain evolving approach to oversight of SaMD based on artificial intelligence and machine learning. Learn more about FDA regulation of medical software and healthcare cybersecurity at Emergo by UL.
Canadian Regulatory Amendments Introduce Expanded Post-Market Surveillance Provisions
New amendments published by Health Canada impose stricter requirements for medical device manufacturers and greater powers for regulatory authorities relating to post-market surveillance and risk management.
2020 Amendments to IEC 62366 – Implications for Medical Device Usability Engineering
Examination of recent amendments to the IEC 62366 standard for medical device usability engineering and how manufacturers are impacted. Learn more at Emergo by UL's Human Factors Research & Design (HFR&D) unit.
US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme
The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020.