Medical Device Software & SaMDs: A Crash Course

A quick and easy rundown of ISO and IEC standards. 
Read More

New Medical Device & Life Science Collaboration Platform

Sierra Policies Quick Start video out now!
Read More

ISO 13485 vs. CFR Part 820

A comparative study on the key differences between FDA’s QSR and ISO’s QMS.
Read More

Shape the future of FDA Regulations for AI/ML.

The proposal for AI/ML based SaMD regulatory framework is out now and you can influence the FDA! 
Read More

Subscribe Here