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
ISO 14971 Risk Management in Under 5 Minutes
Defining medical device risk while taking a sneak peek into ISO 14971:2019.
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
3 Steps to a GxP Cloud!
Do you want to transition to the cloud but have concerns about staying compliant? Below is your 3 step success guide for a digital transformation to a GxP Compliant Cloud.
Read More