• There are no suggestions because the search field is empty.

The Ultimate SaMD Development Plan

Easy Ways to Meet FDA Regulatory Requirements with Your Software Development Plan
Read more

Using Agile in SaMD Development Under IEC 62304

Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development
Read more

What is FDA's 21 CFR Part 820?

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
Read more

What is ISO 13485:2016?

An easily digestible overview of ISO 13485 and how it applies to your medical device company.
Read more

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

Recent Posts

Topics

See all

Subscribe Here