The Business Impact of EUDAMED on Market Access
The European Database on Medical Devices (EUDAMED) is often viewed by manufacturers purely as a compliance burden when…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 1–9 of 624
MedEnvoy at RAPS Euro Convergence 2026
We are excited to share that MedEnvoy will be participating in RAPS Euro Convergence 2026 as an exhibitor! This year’s…
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 …
COFEPRIS Submission Mistakes That Delay Device Approvals
In 2025, Mexico’s COFEPRIS made major changes to its medical device regulatory process in which can produce common submission mistakes…
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 “…
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…
Showing 1–9 of 624