The FDA regulations for DMR appear in 21 CFR Part 820.181, under subpart M which deals with record-keeping requirements for medical device companies. The device master record contains all of the information needed to produce the medical device from beginning to end. While the device history record makes reference to specific lots, units, or batches of product, the DMR contains specifications for producing an individual device. You can think of it as the comprehensive instruction manual for building your device, starting with the design and ending with distribution.
When the FDA audits your medical device company, you will be expected to produce a DMR that complies with 21 CFR Part 820.181. Here's the full text of that part for reference:
Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:(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 main purpose of the device master record is to centralize a record of the production process in a way that distinguishes it from the design process. A product development engineer might design a silicone part for a medical device, draw the design, and include it in the design outputs portion of the design history file, but the DMR would also include specific instructions for manufacturing the part, including what mold to use when casting the silicone, equipment specifications and production methods, and anything else required to produce the part according to the design.
It's so important to understand how the various record-keeping mandates set out by the FDA to fit together, that we've actually written an entire article about it (read it here). Here's a brief summary:
Design History File - The DHF includes a full history of the device design, from the establishment of
Device Master Record - The DMR contains a comprehensive set of data for manufacturing your device. There is significant overlap between DHF and DMR requirements, as the design files are needed to manufacture the product. Items like product specifications and even labeling and packaging were created in the design outputs step - they should already be present in the DHF.
Device History Record - This record contains information about specific batches, lots, or units of product that you produce. It is meant to facilitate traceability of your products throughout their life cycle and to help with root cause analysis by connecting customer feedback and audit results to specific batches of product.
The FDA requires that DMRs are created in compliance with 21 CFR Part 820.40, which mandates document controls throughout the QMS. As your manufacturing process evolves and changes to improve the quality of your devices, your MDR will also change, and you'll need a review and approval process that validates any changes to the DMR. That's where Greenlight Guru comes in - our QMS software includes built-in document controls that support electronic signatures, giving quality managers the ease of reviewing and approving changes to the DMR with the click of a button.
Like the required DHF and DHR documents, your DMR can either include or reference the required materials. Instead of compiling a massive binder of documents, Greenlight QMS allows you to securely store your medical device records where they can be easily referenced in a short DMR document. You'll stay organized, save time and money, and make your next audit a breeze by streamlining your DMR compliance with Greenlight QMS.
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