Title: Module 8 Conclusion
Course: PW-Course-Import-Test > Section: Module 8: ISO 13485

Module 8

At this point in we have concluded the learning modules by walking completely through all 15 subparts of 21 CFR 820 and reviewing the requirements of ISO 13485. You should have a general understanding of the requirements for a compliant USA and International Quality system.

You should be able to answer basic questions about 21 CFR 820 and ISO 13485 regarding the purpose of any of the requirements, what the intent of the requirement is, and what the potential consequences of non-compliance may be.

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 completes the course materials for CEMD 0940. The next step is to take the final exams.