Title: Module 1 Conclusion
Course: PW-Course-Import-Test > Section: Module 1: Introduction to Medical Device Quality Systems

Module 1

In this module we learned why the regulations exist and who they are intended to protect. We learned how the regulations have evolved over the years and how the FDA keeps up with “changing times.” We learned about the enforcement structure and what the consequences of non-compliance can be. We learned how to access current industry inspection results so that we can be prepared to help our current/potential employers remain complaint to the regulations.

Study these Take-Away Notes for a review of the main points of this module. You can think of it as a study guide for your assessments.

This Study Guide identifies the key learning points that will be discussed in the following modules.

Coming Up...

In the next module we will continue our exploration of 21 CFR 820 by covering Subpart C - Design Controls. Design Controls are arguably the most critical element of QSR compliance for firms that do research and development for medical devices. The safety and efficacy of a medical device must be established, documented and reviewed throughout each step of the Design lifecycle. We will cover these important elements in Module 2.