US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septemb...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Guidance on Laboratory Developed Tests: Small Entity Complianc...
EU Portable Electronic Devices Change Requirements
Portable Electronic Devices (PED) include digital cameras, smartph...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, April 2024
USA
FDA Data Standards Catalog Version 10.3
The FDA Data Standards...
Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across the globe. Each c...
US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fede...
