DMR Index - Can someone share their Device Master Record Index structure or format?

[sardonyx]

Can someone share their DMR Index structure or format?
Our contract manufacturer is asking for a DMR Index and they even asked for the manufacturer's name and part number of each component. Is this valid? I thought BOM which contain manufacturer and part number would be enough and we don't have to specify those in the DMR Index. Please advise. If you can send me a sample that would be great.

 

[Al Rosen]

Re: DMR Index - Can someone share their Device Master Record Index format

Can someone share their DMR Index structure or format?
Our contract manufacturer is asking for a DMR Index and they even asked for the manufacturer's name and part number of each component. Is this valid? I thought BOM which contain manufacturer and part number would be enough and we don't have to specify those in the DMR Index. Please advise. If you can send me a sample that would be great.

It's just a list of the documents, including the revision level, that are required to manufacture the device. You can use a family tree if you like. Don't complicate something simple.

 

[sardonyx]

Re: DMR Index - Can someone share their Device Master Record Index format

Hi Al,

That's what I thought too! I don't know why our contract manufacturer is asking for too much detailed of a DMR index How do I convince them that we do not have to provide them the manufacturer and manufacturer's part number of each components since this is like an approved vendor's list (AVL) already. I think these information can be included in the BOM and no need to add in the DMR index. Am I right?

 

[ontheopenroad]

Re: DMR Index - Can someone share their DMR Index structure or format?

If they are your contract manufacturer, shouldn't they have the bill of materials already? If you are specifying which materials to use, that would be in your specification that you issue to them. They should be generating their own DMR document under their internal procedure based on your specification.

(or am I wrong?)

ps We are a contract manufacturer, and we create our own BOM and DMR based on our customer's specifications. Our customers never see our DMRs unless they come in to perform an audit.

 

[sardonyx]

Re: DMR Index - Can someone share their Device Master Record Index format

That's a good idea! I should tell them that. Tomorrow is our meeting with our CM maybe I can tell them that they suppose to create their own DMR and BOM based on our specs. Thanks ontheopenroad!

 

[Marc]

Re: DMR Index - Can someone share their DMR Index structure or format?

What is a DMR? Document Management Report or something?

 

[Ajit Basrur]

Re: DMR Index - Can someone share their Device Master Record Index format

Device Master Record

 

[wspencer]

Maybe this will help...

HHS Publication FDA 97-4179, Section 8 "Device Master Records"
http://www.fda.gov/cdrh/qsr/08dmr.html.

Also attached is a copy of the Device Master Index for one of the products we manufacture. A lot of the documents are not in the Device Master Record, but are referenced in the DMR as to where the document is located (Document Control Office, Engineering Library, etc.). I have removed the name of the company and approval signatures from the attached.
Let me know if the attachment didn't come through.

wspencer

 

[sardonyx]

Thanks wspencer for the DMR index sample. It helps to create our own one based from your sample.

 

[Microbe]

I have a bit of a problem here with DMR's.

The template supplied by wspencer appears to be very comprehesive and detailed, and i'm sure it is what the FDA would like to see. My concern is over the amount of work necessary to generate such a document if it is not going to be used. If people within the organisation use it, then that is fine and it may be worth all the work. If however its sole purpose is to satisfy the FDA, then it does not contribute much to your organisation. If this is the case then in my opinion you should just do the minimum to satisfy the requirements of the QSr and that should be it.

A bit like Quality manuals really, but that is another topic......

Hope this helps

Microbe