Definition of the term („Was is a Device Master Record?“)
A Device Master Record is a technical product file with compilation of records which includes the processes and specifications for an end product (FDA 21 CFR 820). The term Device Master Record was coined by the US Food and Drug Administration (FDA) and is part of the Quality System Regulation (QSR).
What is the connection to the FDA?
As the developments in the sector of medical devices have significantly increased in recent years, the regulating approval authorities are also constantly facing new challenges. This way, the FDA (Food and Drug Administration) with its reliability and strict regulation serves as an international model. With reference to the FDA, the Device Master Record is an aspect of the extensive documentation system aiming at regulating the quality management of medical devices. While the FDA focuses on devices of the US American market, the revision of ISO 13485(:2016) and the associated Medical Device File now also makes documentation for quality assurance mandatory in Europe.
What does a Device Master Record contain?
- Intended purpose
- Information on the structure of the device (sketches, compositions, components, software used)
- Production information (tools, processes, methods, production requirements and specifications)
- Quality assurance procedures (methods, tools, etc.)
- Labelling information (packaging, device information, etc.)
- Installation, maintenance, storage and transport instructions including methods and tools