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class iii medical device, device master record (dmr), 21 cfr part 820 - med. device mfger. qsr requirements
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  #1  
Old 22nd February 2005, 05:29 AM
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Please Help! DMR - Device Master Records - What is the best way to structure the DMR

I wonder if it is possible for someone to give me some advice. We are a small medical device company, primarily selling with the EU - so we have technical files/design history files for our products.

We also sell a small amount to the US, but have plans to expand. It is likely that at some stage we will be audited by the FDA. We have in place a DMR within our QMS for each of our products, but it does appear to be a useless and redundant document, as all the information is held elsewhere within our system.

I am fundamentally against having un-necessary documentation, and would ideally like to be able to use the information that we already have ie the technical faile and design history file. If this is not possible, what is the best way to structure the DMR, giving maximum benefit for minimum hassle. Are there any templates out there?

Many thanks for any help/advice offered

Microbe

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Old 22nd February 2005, 09:06 AM
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In Reply to Parent Post by Microbe

I wonder if it is possible for someone to give me some advice. We are a small medical device company, primarily selling with the EU - so we have technical files/design history files for our products.

We also sell a small amount to the US, but have plans to expand. It is likely that at some stage we will be audited by the FDA. We have in place a DMR within our QMS for each of our products, but it does appear to be a useless and redundant document, as all the information is held elsewhere within our system.

I am fundamentally against having un-necessary documentation, and would ideally like to be able to use the information that we already have ie the technical faile and design history file. If this is not possible, what is the best way to structure the DMR, giving maximum benefit for minimum hassle. Are there any templates out there?

Many thanks for any help/advice offered

Microbe
The DMR is not a document, but a collection of all the documents required to manufacture and test the device. All that is required is an index to point to where the documents are. Your technical file can do this since it too may be an index of where these documents can be found.

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Last edited by Al Rosen; 22nd February 2005 at 09:10 AM.
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Old 23rd February 2005, 05:28 AM
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Thanks Al,

We should be able to use the exisiting indexes from our design history files. From my reading, the DMR should be controlled and formally approved for each change. It should list the revisions of all the documents mentioned within it. Am I correct?

I guess that my main problem with the DMR is that I just don't see it's worth. I've seen a number of medical device companies within Europe, and all of them struggle with the concept.

Many thanks
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Old 23rd February 2005, 08:44 AM
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In Reply to Parent Post by Microbe

Thanks Al,

We should be able to use the exisiting indexes from our design history files. From my reading, the DMR should be controlled and formally approved for each change. It should list the revisions of all the documents mentioned within it. Am I correct?

I guess that my main problem with the DMR is that I just don't see it's worth. I've seen a number of medical device companies within Europe, and all of them struggle with the concept.

Many thanks
Somewhere you must maintain control of your documents (ISO 13485, 4.2.3). Is there a master list of all of your documents including the revision level? If this contains more than the required documents then you can use a subset or make a notation to identify the documents that are part of the DMR. We have a master list of all our documents. It lists , Title, Document No. & Rev Level. The index has a revision date. Do you have something similar that might be used for this purpose?

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Old 23rd February 2005, 01:47 PM
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DMR is a document

The DMR at our company is a formally controlled quality system document. Technical files are more Regulatory at our company, and are not accessible to everyone. DMRs are. We are a contract manufacturer. There is one for each product, and we use it as a document index. There are no references to the document revision levels as those are on the documents themselves, as well as the document history, including ECO number. If you need a template I have one.

The principle behind using the DMR as an index all documents, drawings, etc. that are used to build a device is that it makes auditing easier, and is a great resource for new people who are not familiar with the device.

It is structured like this:

DEVICE MASTER RECORD
Product Number:
Revision:
Product Description: (Noun name, modifier, value)
Customer name:
Design history file: (This could be your project file with design xfer.)
Raw materials spec: (doc number, no revision. Go to document
itself for the current revision number and
history.)
Bill of Material: (doc number) BOM has component numbers of
course
Drawing number: (Drawing number(s))
Manufacturing procedures: List doc numbers
Quality assurance procedures: List doc numbers
Fixtures: See individual manufacturing and quality assurance specs. (We do not list fixtures on DMR and in specs. Only at point of use.)
Software: Name software packages
Packaging procedure:
Packaging info: Shelf life in days
Number of units in this configuration that is shipped
(eaches, 10 to a carton, what. A DMR for each
configuration.)
Labeling: Labeling procedure
Label printing spec: Doc number
Post Packaging testing: Doc number
Sterilization: Doc number
Post sterilization inspection and testing: Doc number
Inspection and release procedures: Doc number
Shipping: Doc number

At the end of the document is the revision history including rev. number, effective date, ECO number, and short description of change.

Hope this helps. Also useful for you would be this link:
http://www.fda.gov/cdrh/dsma/gmpman.html

Included in this manual is what the FDA says a DMR should be. Along with a lot of other info. That should help you a lot.
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Old 8th April 2005, 07:36 PM
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Advice from an ex FDA Inspector

On a recent training session conducted by 2 ex FDA Inspectors with near 50 years FDA between them we were given the advice that the DMR should be the instructions on how to build the product. It is a shopping list, the recipe and instructions, complete with all diagrams and drawings. It should also have reference to the way you designed the product and show what steps you have taken to improve or change the product.

Our DMR was a simple list of all procedures, drawings, etc, in fact everything that went near the product was listed. The 2 ex FDA inspectors said our list did comply with 21 CFR pt 820 but it was not what was intended, it was not in the spirit of 21 CFR pt 820 and it was a pretty useless document.

If the DMR is constructed to show the build/manufacture sequence of the product it can also be linked and constructed to resemble the DHR as well because the ingredients and processes used to make the product follow the same order. That way explaining the 2 to an auditor is so simple.

If the same product is packaged into many configurations then build the product to the point where the packaging and labelling are different as one DMR and then form the last part of the DMR as multiple Bills of Materials and marry the 2 together to show the configuration of the final product.

If anyone has a DMR they are willing to share, please do as we are trying to change ours for the better. All ideas welcome.

Mick B
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Old 11th April 2005, 01:58 PM
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Our DMRs are constructed to follow the manufacturing sequence. It's easy for manufacturing personnel to follow. The DMRs also contain the design information by mapping back to our customer's design transfer file.

DMRs are very dependent upon what product you're making. For my company to construct a DMR according to the instructions the ex-FDA instructors gave you would be highly impractical for our business.

To see an example of what the FDA thinks a DMR should look like, please see that attached DMR info from an FDA publication. Personally, I don't like it.
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: doc Device Master Records.doc (597.5 KB, 3627 views)
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Old 22nd October 2005, 05:53 PM
Chan J Chan J is offline
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Must all documents in DMR/DMF be approved 1st

Hello, our contractors are helping us out in a portion of designing and pre-paring it for pre-production of our product. We are getting our CE mark for our product and hence our manufacturers need to only meet the 13485 requirements. I believe in 13485, it is not needed to have a DMR but just some contents of the DMR. Two questions arouse as I was in the process of preparing them for the audit.


i) Can the file containing all the documents for the DMR have another name (currently, they call it a project file, and what it contains are design inputs, outputs,review, verification, engineering drawings, BOM, production processes.)

ii) must all the documents have approval signature(s)? Are e-mails sufficient enough as objective evidence that the documents has been approved?

I've read the DMR guidance attached in this forum on the signature and approval part, but as I know DMR is more to the FDA requirement and not ISO13485.Can anyone share their experiences and hopefully answer my questions as well...thanks a million.
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