Medical Device Adverse Event Reporting Regulations: EU vs. US FDA
Regulatory authorities in both Europe and the United States requir...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025
USA
Guidance on Premarket Approval Application and Humanitarian De...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Oct 2024
USA
Guidance on Considerations for Long-Term Clinical Neurodevelop...
Steps to Implement ISO 13485 for New Medical Device Vendors
For medical device vendors entering the industry, obtaining ISO 13...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Sept 2024
USA Air Powered Dental Handpieces and Air Motors – Performance Cri...
US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septemb...
