The Device Master Record is a document requested according to FDA 21 CFR 820 regulation and having wall organised device master record example and template is essential. The DMR is basically considered the collection of all the information needed to manufacture a specific medical device.
It is not necessary that the device master record contains itself all the information, however it should at least reference all the necessary information.
21 CFR 820.181 defines very precisely what shall be included in the device master record template:
(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
(d) Packaging and labeling specifications, including methods and processes used; and
(e) Installation, maintenance, and servicing procedures and methods.
The DMR is an essential document for the design process of medical devices, it contains all the information to manufacture the device, including information on manufacturing quality process and incoming controls on materials, packaging, labelling, etc. It includes as well documentation onto activities to be performed on the device once it is out from the manufacturing location, such as installation, maintenance and servicing activities.
Here at QualityMedDev, we present a Device Master Record Template example that could be used as starting point for the construction of your DMR. The template is a 6 pages long Word document containing a clear structure and related suggestion/indications on how to prepare the Device Master Record of your device
This Device Master Record Template example is fully editable in word, can be used as starting point for the construction of your risk management process and it is fully compliant with FDA regulation
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