James (Jim) Dent, LSSBB, DTMx2 'Design' History File and 'Design' Master Record are typical in other industries outside of of medical industry. Others industries seldom use the term 'Device.' The variations in what is used can easily be the result of common practices at the previous company an employee came from, and over time become the common practice at the current company.

In the medical device field, I think it would be best to use the terms as described by the FDA in the link Brett provided above.

Abdul Haleem Yes, chris is absolutely right

Abdul Haleem D=device

Aaron Liang As Jim noted, I think it is always good to be consistent with the FDA terminology that Brett provided in his link. However, I do see a point in providing differentiation for the DMR/DHR for documenting the activities and transition between design and final production. For example instead of changing the core DMR/DHR terms one could apply a prefix to them to identify the stage of product development that they apply to such as a design or test DMR/DHR and then a final released DMR/DHR.

Paul Marshall, CPPL, PMP keep in mind that the FDA also considers packaging as part of the device. When reading 21 CFR, interchanging packaging with device will outline packaging DHF and DMR requirements.

Ginger Cantor The DHF is the Design History File. That's where the D is design.

Brian Dawson Here is a little more narrative in support of the prior comments by Ginger and Joanne. During the development process, conducted in accordance with the Design Control requirements, the Device Master Record (DMR) is created and the Design History File (DHF) is the record that demonstrates the Design Control process was completed properly. Also during development, product is manufactured for design validation, process validation and other needs. Whenever product is produced there is a Device History Record (DHR) which must demonstrate the product was made in accordance with the Device Master Record (DMR) in effect at that time.

I find it helps to focus on these two relationships:
1. The DHF (design) shows how the DMR (device) was DESIGNED.

1. The DHR (device) shows that DEVICE was made according to the DMR (device).

Love this. Thanks to all for generously sharing your expertise with Chris. Makes me proud to lead the group.

Thanks a lot for clearing up this subtle but important difference

James Werner The DMR an output of the DESIGN. It includes all of the requirements (specifications, procedures, test methods, etc.), including packaging and labeling, to make the medical device. The DHR contains the records to provide objective evidence the device was made according to the DMR "and" FDA requirements found in Part 820 were followed. It is common to think that the DHR only applies to manufacturing records - this is incorrect.

Mark Frampton Adding to James mention for manufacturing records... MBR - Master Batch Records (travelers) compiled to the LHR - Lot History Record (travelers, certs, limit samples, deviations, events)

Ginger Cantor Mark has added other terms of MBRs and LHRs. Most device manufacturers I have audited and worked with do not user the term MBRs they use "DMR" and "DHR" since they are defined in the device regulations.

You see the MBR acronym used more in drug or biological product manufacturing, accompanied by the acronym PBR (Production Batch Record) which is an exact copy of the MBR. The PBR can and did physically "travel" as hard copy through the process (and this matches up with "Travelers" and perhaps some companies use of the terminology "LHR" in the device world).

In an electronic world though, the terminology on Travelers might be outdated eventually if at some point nobody will use hard copy. But that still won't happen for a long long time, especially in small companies who cannot afford or do not implement electronic 21 CFR Part11 compliant systems.

Mark Frampton True Ginger, It's good to know the variants. Companies seem to harbor on their own legacy of terms. Every time I walk into a new environment there is the task of mingling terms.

I will say that since I am more attached to research and development, the paper travelers are generally the medium where system requirements likely do not yet exist. At the end of the lot, all are scanned and uploaded to the repository.

I have been in the medical device industry since 1990 and this is the first time I have seen Design used to the DMR and DHR prior to commercialization. Typically, during product design and development phases, the term DHF (Design History File) is used to capture design related documentation.

Prior to commercialization, I typically keep the DMR and DHF documentation at numeric revision, and then revise them to alpha revision after the final, completed design/phase review.

Marie Suetsugu Oops...I had mistakenly spelled out the 'DHF' as 'device ~' too :-$ Thanks very much for this thread!