The Device Master Record (DMR) is one of the ‘holy trinity’ of files that developers need to collate and maintain in order to prove compliance with FDA medical device regulations These files, specified in FDA 21 CFR Part 820.181 are the Design History File (DHF), the Device History Record (DHR) and the Device Master Record (DMR) itself.
DHF vs DMR: What's the difference?
The DHF captures the history of your design decision making. It demonstrates to auditors you have controlled the design process according to the regulation. The Device History Record, on the other hand, is the proof that you have manufactured the device exactly according to those design specifications.
The Device Master Record, meanwhile, is focused on the way your device should be built. The DMR is the ‘recipe’ for the safe and successful manufacture of your product, as well as its subsequent product management. It is a required output of your design process. It is the document that you will transfer to production and which they will use to set up and run a compliant manufacturing process. Because of this, it must be accurate, up-to-date, unambiguous and accessible by the right people at any time.
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How does the FDA define the DMR?
The contents and requirement for your DMR are specified in 21 CFR PART 820 Subpart M in the following way:
“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.”
What are the typical contents of a DMR?
A Device Master Record for a medical device, typically includes the following documentation:
- Declaration of conformity (DOC)
- Intended use of the product
- Product specification and drawing specifications
- Risk management documentation
- Product and process testing
- Sterility testing
- Shelf life requirements
- Quality control instructions and forms
- Information on components
- Instructions for use and labeling
- Clinical files
- Sales collateral
- Change request records
- Complaint process
- CAPA history
Anyone who accesses these files would have all the information they need to manufacture and manage your product safely, effectively, and exactly as the regulation requires. At the same time, they will while having complete visibility about how these documents were iterated, approved and assembled.
Why paper based or a DIY digital approach will fail you as you build your DMR
Trying to manually organise your DMR using paper or a DIY digital approach can be a nightmare As you can see from the above, a DMR is not a collection of static documents. There’s a lot of moving parts involved and a lot of cross over between the contents of your DHF, DMR and DHR. Without a dedicated document control system to help you, it can end up being a hugely confusing and error-prone task.
You can end up with records copied and pasted into some folders but missing from others. Spreadsheets can end up full of broken links as files are updated and URLs changed. You can end up wasting time and duplicating effort preparing the same documents for review.
Instead, medical device developers need an automated, electronic document management system (eDMS) to help them build and maintain their DMR in the most efficient, organised and methodical way possible.
Three reasons you need an electronic document management system (eDMS) to build your DMR
1. Documents in a modern multi-discipline medical device build, are complex and ever changing. Product requirements and designs can be iterated and finalised by different people in fast succession. Documents bounce between teams and move from draft status to become approved engineering specifications, drawings and BOM, following multiple corrections and authorisations If you’ve got many different people working on documentation and sharing updates with emails, documents can easily be misfiled, written over, or simply go missing. Without the right document controls in place the DMR can quickly become a disorganised mess.
2. Spreadsheets and standard file sharing apps (like Google Drive or DropBox) do not have the built in processes for managing engineering change control. Manual routing of change control requests by paper or email takes time, results in bottle necks and can result in serious mistakes. You need to choose an eDMS that can automate your DMR change control process reducing the risk of errors and omissions. An eDMS can ensure all change requests are subject to appropriate authorisation and validation, while details of each change made to the documents can be recorded automatically in their audit trail. With these change controls in place, at anytime in your product lifecyle your DMR should accurately reflect the ‘way you do things’ in your manufacturing process and show how these decisions were made.
3. Data and documents within your DMR are relational. Documents will contain vital links to previous versions and other documents in other parts of your QMS (Quality Management System). The same performance data will be used as evidence in multiple documents. To avoid confusion and duplication you need to choose an eDMS that lets the same documents live in different parts of your system at the same time, while keeping their internal links intact and safe from unauthorised change. When authorised changes to documents are made, they should appear everywhere in the system where the document is visible. This kind of sophisticated document management is simply not possible with a Google Drive or DropBox solution. You need specialist tools to do the job.
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Keep sane and carry on
Using a dedicated electronic document management system to build and maintain your DMR is the best way to effectively manage your manufacturing data and your sanity.
Choose a system that lets you define the contents of your DMR at the start of your project, with your folder automatically populating approved content as your development progresses. When your device is in production your DMR should be the definitive record of all your manufacturing and product management processes.
With the right document control tools, it’s possible to build a DMR that is logically structured, secure, accessible and kept up-to–date in real-time. But trying to achieve all this using Google Docs, DropBox and an Excel sheet will really tie you up in knots.