10-Step Guide to Start Selling Medical Devices in Europe
Selling medical devices in Europe is strategically valuable because the EU market is one of the largest and most regulated healthcare markets in the world. Achieving CE marking under the EU MDR or IVDR not only allows entry into Europe but also signals global...
Health Canada Post-Market Surveillance Requirements
Health Canada requires medical device manufacturers to conduct ongoing post-market surveillance. Mandatory summary reports, issue-related analyses, incident reporting, and foreign risk notifications are necessary requirements. Notably, these obligations apply...
Health Canada MDEL Renewal Checklist for MDEL ALR
MDEL annual license review (ALR) is a yearly renewal process for companies manufacturing, importing, or distributing medical devices in Canada. Health Canada oversees the ALR process. This review process ensures that MDEL holders remain consistently compliant with the...
CE Marking for Cardiovascular Medical Devices: Your Guide
CE marking is mandatory for marketing your cardiovascular medical devices in the EU market. It demonstrates compliance with EU MDR guidelines. The process of CE marking for cardiovascular medical devices is a rigorous, multi-step pathway. It ensures safety,...