Title: Why Are Medical Device Records Part of the Regulation?
Course: PW-Course-Import-Test > Section: Module 6: Quality Records

Module 6

Medical Device records are required to provide objective evidence that required activities were properly documented, conducted and recorded.

- The Device Master Record - as its title describes - is a master record that essentially contains the entire document “recipe” required to manufacture the medical device.
- Device History Records are individual records of each medical device (of batch of devices) that are manufactured in accordance with the DMR.
- Quality System Records are records of the Quality System, including those contained in the Quality Manual and records generated from Quality System processes.
- Complaint Files are records generated from the Complaint process and capture information which could be related to allegations or incidents of failure to meet specifications, malfunctions, etc.

Watch

Watch this video for an overview of 21 CFR 820.180 Subpart M (Records - General Requirements). This video also covers 21 CFR 820.181 Device Master Records, 21 CFR 820.184 Device History Records, 21 CFR 820.186 Quality System Records and 21 CFR 820.198 Complaint Files (these are all part of Subpart M).

Watch the following video which explores some different aspects of Quality Records, including numbering schemes (to easily identify documents in your quality system library) and “intuitive” schemes that can make it easier on quality system participants to find documents and remain compliant to the regulations. There is also some additional detailed information about the Design History File (DHF), DMR and DHR.

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR)

Read

Read Subpart M Quality Records General Requirements

Read Subpart M - Complaint Files

Take the practice quiz on the next page to check your knowledge and then join the Learning Community to discuss Quality Records