Sierra Policies Quick Start video out now!

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

Defining medical device risk while taking a sneak peek into ISO 14971:2019.

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

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.

Breaking down the basics of Software as a Medical Device (SaMD): risk categorizations and examples.

Learn how to implement Agile into your SaMD development and also stay compliant.