Title: Module 6 Overview: Quality Records
Course: PW-Course-Import-Test > Section: Module 6: Quality Records

Module 6

One of the common definitions for a medical device Quality System is that it is a “documented library” that comprises the Quality System. Quality System documents are records of the Quality System. Design History Files are records of the Design Process. CAPA records, Complaint records, Device History Records, etc. are records produced to support a Quality System requirement. All of these are considered Quality Records, and as such have specific requirements regarding their preservation, storage, retrieval, electronic storage (as applicable), etc.

Medical Device records are required to provide objective evidence that activities required by the regulation were properly conducted, documented and / or recorded.

In this module we will review the regulatory requirements associated with 21 CFR 820 Subpart M.

Competency

After completing this module, you will be able to explain the significance of medical device record retention and controls.

Learning Objectives

- List the key reasons records are required.
- Describe three (3) potential consequences of non compliance to device record retention requirements.

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