Common QMS Mistakes SaMD Companies Make

What kind of QMS mistakes and pitfalls do SaMD companies run into? How can they avoid pitfalls around their QMS?

Today’s guest is with Karandeep Singh Badwal. He is aRegulatory Affairs Quality Consultant who happens to be well-versed in EU MDR which is very important these days. He also works with class 1, 2, and 3 medical devices.

Listen to what Karandeep has to say about what a quality management system is and what it is meant to achieve, the importance of validating software, and the differences between AI and machine learning, among other things.