Medical Device Compliance: 2025 Insights & 2026 Priorities
As 2025 ends and 2026 begins, medical device and IVD manufacturers continue to navigate an increasingly complex global regulatory environment…
Resources & News
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RAPS Convergence 2025 MedEnvoy Key Takeaways
From October 7–9, the MedEnvoy team attended RAPS Convergence 2025 in Pittsburgh, joining global leaders, innovators, and policymakers to explore…
Economic Operators Under the MDR and IVDR
This webinar breaks down the roles and responsibilities of economic operators under the MDR and IVDR.
MDR QMS Notified Body Assessment
Webinar: MDR QMS Notified Body Assessment
Understanding MDR and IVDR Post Market Surveillance
Explore key elements of Post Market Surveillance (PMS) under MDR and IVDR in our latest webinar.
Understanding Technical Documentation Under MDR
In our recent webinar, part of our four-part MDR and IVDR compliance series, we explored the complex and…
Navigating COFEPRIS: Medical Device Distribution in Mexico
Mexico is one of the largest importers of medical devices in Latin America yet the importation process is highly…
New Zealand Medical Device Registration Guide
Unlike some medical device regulators, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) does not require pre-market approval…
Saudi Arabia Medical Device Registration Requirements
The Saudi Food and Drug Administration (SFDA) has aligned its medical device regulatory requirements with other major market frameworks,…
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