Device Master Record (DMR) that was compiled by another company

Hello,

I have been going through a Device Master Record (DMR) that was compiled by another company. This DMR is for a product that my company purchased several months ago. They sent us the DMR & DHF shortly after we purchased the product.

My question is that the DMR that they sent us includes all versions of each of the documents in the DMR. Is this the correct practice? If possible, I would prefer to keep the superseded documents in a separate file. I think that would make the the current documents will be more readily accessible, but I want to make sure that is okay to do.

Thanks,
Jim

Re: Quick question on device DMRs

IMO, stating the version/revision level of the documents in the DMR is just making additional unnecessary work for someone. Every time one of those documents is revised, the DMR will need to be revised, as well. Our DMR does not include the version/revision level of the documents related to the product.

Re: Quick question on device DMRs

GStough said:

IMO, stating the version/revision level of the documents in the DMR is just making additional unnecessary work for someone. Every time one of those documents is revised, the DMR will need to be revised, as well. Our DMR does not include the version/revision level of the documents related to the product.

Click to expand...

Good idea

We include the version number in the DMR and hence the changes to the DMR is very often.

Gidget has a valid point that is worth considering.

Re: Quick question on device DMRs

GStough said:

IMO, stating the version/revision level of the documents in the DMR is just making additional unnecessary work for someone. Every time one of those documents is revised, the DMR will need to be revised, as well. Our DMR does not include the version/revision level of the documents related to the product.

Click to expand...

I take it that your product range must not include some products that utilize one revision level of a given document, and other products that utilize another revision level of that same document?

That's fairly common for us, both in regard to customer documentation for contract manufactured products, and our own documentation for some of our longer-lived product families. For instance, a range of OEM products might include some that utilize rev 12 of their corporate label specification, some that utilize rev 13, and others rev 14.

We also very commonly have documents for which a particular revision is working its way through the development and approval process, but has not yet been fully approved for a particular application. That document must be fully controlled, and is the latest rev level, but certainly we can't apply it yet.

Because we can't assume that the latest version is effective, we don't allow any reference to a controlled document that doesn't also include a reference to the applicable rev or version level.

Re: Quick question on device DMRs

MIREGMGR said:

I take it that your product range must not include some products that utilize one revision level of a given document, and other products that utilize another revision level of that same document?

That's fairly common for us, both in regard to customer documentation for contract manufactured products, and our own documentation for some of our longer-lived product families. For instance, a range of OEM products might include some that utilize rev 12 of their corporate label specification, some that utilize rev 13, and others rev 14.

We also very commonly have documents for which a particular revision is working its way through the development and approval process, but has not yet been fully approved for a particular application. That document must be fully controlled, and is the latest rev level, but certainly we can't apply it yet.

Because we can't assume that the latest version is effective, we don't allow any reference to a controlled document that doesn't also include a reference to the applicable rev or version level.

Click to expand...

The one medical device that our facility produces is unique from the other products we make here. Most of the materials that go into its production are almost exclusive to that one device, so I would say "yes" to your question.

It is also an almost entirely manual process, so the operator is fully involved and in complete control of the process at all times. Production is run as-needed and on a much smaller scale than our other products.

Re: Quick question on device DMRs

MIREGMGR said:

I take it that your product range must not include some products that utilize one revision level of a given document, and other products that utilize another revision level of that same document?

That's fairly common for us, both in regard to customer documentation for contract manufactured products, and our own documentation for some of our longer-lived product families. For instance, a range of OEM products might include some that utilize rev 12 of their corporate label specification, some that utilize rev 13, and others rev 14.

We also very commonly have documents for which a particular revision is working its way through the development and approval process, but has not yet been fully approved for a particular application. That document must be fully controlled, and is the latest rev level, but certainly we can't apply it yet.

Because we can't assume that the latest version is effective, we don't allow any reference to a controlled document that doesn't also include a reference to the applicable rev or version level.

Click to expand...

I like this.

Device Master Record (DMR) is the FDA's QSR requirement BUT we received a NCR from TUV ISO 13485 Auditor as follows, "The device master file is not defined in the quality management system and not established according to ISO 13485: 2003 or QSR 820". We can produce a FILE but not necessary it is called a device master file as mentioned under clause 4.2 that "For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing."

We do have such a file and documented under Technical File and we do not called it Device Master File! Do we have to re-name our Techncial File as Device Master File???

1.) We maintain separate Technical Files and DMRs for our products since they target two different audiences.

2.) in our Technical FIle (TF) we do not put the revisions of the controlled documents.

3.) We do not want to put the revisions of docs in our DMRs (to minimize maintenance as other have stated), but have experienced that the DMR is thought to be the document which records the exact configuration of a specific version of a medical device. We have found we would have to include at least the version of the software supplied with the device. Otherwise the version that production is suppose to install is not called out anywhere. This immediately creates an exception to our thinking that we could not include revisions in the DMR and be OK.

I would like to know what other are doing in regards to the exact revisions of documents found on their DMRs.
THanks to everyone in advance for their comments!