US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fede...
US FDA Medical Device Labeling Requirements
What Is Medical Device Labeling?
According to the FDA, medical dev...
Differences between US FDA and EU MDR Usability Studies requirements
Regulatory frameworks for usability testing
IEC 62366-1:2015 is an...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Oct 2023
USA | EUROPE | ASIA
USA Guiding Principles on Predetermined Change...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Sept 2023
USA | EUROPE | ASIA
USA (FDA) Electronic Submission Template for M...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Aug 2023
USA | EUROPE | ASIA
USA (FDA) Informed Consent Guidance for IRBs, ...
