FDA Guidance on General Wellness: Policy for Low-Risk Devices
The FDA released a revised final version of its guidance, General Wellness: Policy for Low Risk Devices, on January 6, 2026.
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FDA Final Guidance: Clinical Decision Support Software
The U.S. Food and Drug Administration (FDA) released an updated final guidance document titled “…
EUDAMED & swissdamed: Mandatory Registration for 2026
Preparing for EUDAMED & swissdamed As global regulatory systems continue evolving, medical device manufacturers must stay ahead of changing requirements…
FDA Transitions to QMSR: Immediate Actions for Manufacturers
Effective Monday, February 2, 2026, the FDA officially transitioned to the Quality Management System Regulation…
EUDAMED Registration Mistakes and How to Avoid Them
The European Database on Medical Devices (EUDAMED) is a centralized electronic system established under…
FDA Guidance on Cuffless Blood Pressure Measuring Devices
The FDA officially released the draft guidance “Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing…
World Health Expo Dubai 2026
Schedule a Meeting at WHX Dubai 2026 MedEnvoy at WHX Dubai 2026 MedEnvoy is…
EU Publishes MDCG Guidance on Post-Market Surveillance
As of December 2025, The Medical Device Coordination Group (MDCG) has published MDCG 2025-10, providing comprehensive guidance on post-market surveillance…
The Business Impact of EUDAMED and Staying Compliant
The European Database on Medical Devices (EUDAMED) is often viewed by manufacturers purely as a compliance burden, serving…
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