Key FDA Changes MedTech Manufacturers Need to Know
The FDA has issued an update for MedTech Manufacturers to its List of FDA-Recognized Consensus Standards, published as …
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Changes to Health Canada Medical Device Applications
Health Canada has issued several guidance documents that take effect in early 2026 and will directly impact how medical device applications must…
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.
FDA Final Guidance: Clinical Decision Support Software
The U.S. Food and Drug Administration (FDA) released an updated final guidance document titled “…
FDA Transitions to QMSR: Immediate Actions for Manufacturers
Effective Monday, February 2, 2026, the FDA officially transitioned to the Quality Management System Regulation…
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The FDA officially released the draft guidance “Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing…
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…
FDA Issues Updated Final eCopy Submission Guidance
The FDA issued an updated final guidance document titled “eCopy Program for Medical Device Submissions” on…
MDCG Master UDI-DI Timelines: Contact Lenses and Spectacles
The Medical Device Coordination Group (MDCG) has published MDCG 2025-7 Rev. 1 (December 2025), a position…
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