The IGJ Highlights the Importance of an Effective PMS System
The inspections conducted by the Healthcare and Youth Care Inspectorate (IGJ), based in the Netherlands, focused on evaluating manufacturers’ adherence to Post-Market…
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Australia 3G Shutdown in Oct 2024 May Impact Medical Devices
The decommissioning of 3G networks in favor of more advanced 4G and 5G networks may affect medical devices and products…
MDCG Guidance Clarifies IVDR Product Classification and Scope
Despite over a year having passed since publication of Version 3 of the Manual on borderline and…
The Essential Guide to EU MDR Medical Device Classification
Early device classification is essential, especially if you have a complex…
MDCG Guidance on CAPA Plan Assessment for Notified Bodies
The MDCG (Medical Device Coordination Group) has released a guidance document titled “Corrective and Preventive Action (CAPA)…
EMA Launches Pilot Program for Orphan Medical Devices in EU
The European Medicines Agency (EMA) has launched a pilot program aimed at supporting manufacturers of high-risk medical…
IGJ Report Urges Medical Device Manufacturers to Prioritize PMS
The IGJ, or the National Competent Authority of the Netherlands, published a report as a call to manufacturers to focus…
EU-Swiss Medtech Industry Supports MRA Update Negotiations
A joint statement by Swiss Medtech, SVDI, and MedTech Europe highlights the industry’s support for the ongoing EU-Switzerland negotiations…
RAPS Convergence 2024: MedEnvoy Key Takeaways
From September 17th to 19th, 2024, the MedEnvoy team attended RAPS Convergence 2024. This event brought together regulatory affairs…
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