Title: Module 2 Conclusion
Course: PW-Course-Import-Test > Section: Module 2: Design Controls

Module 2

In this module we covered 21 CFR 820.30 Subpart C - Design Controls. We explored why Design Controls are important with respect to consumer protection and safety. We stepped through the Design Control Guidance document to gain a greater understanding of specific Design Control requirements. We looked at some visual examples of a real life Design Control process to gain a greater appreciation of the potential complexity involved with this critical process.

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.

Coming Up...

In the next module we will cover 21 CFR 820.40 Subpart D - Document Controls. The Quality System is comprised of a library of documents that describe all aspects of the Quality System and all approved Medical Device products. The requirements for the control of documents are critical in order to maintain a state of compliance. We will explore the importance of Document Controls, the frequency in which non-compliances related to this section of the regulation occur across the industry, and the consequences of non-compliance.