DMR (Device Master Record) For Contract Manufacturers

B

bkabitz

#1
I work for a company in the US. We have a sister company in Ireland we are using as a contract manufacturer for some of our Class II devices. We own the design in the USA (i.e., we designed the device and maintain the DHF, DMR, 510(f), etc.), and the sister company in Ireland is ISO 13485 certified, but they took an exemption for Design Controls due to the fact that they do Not design devices, they only manufacture on a contract basis.

My question/concern is: They are maintaining a DMR in Ireland for all the devices they are manufacturing, is this necessary?

I’m thinking the “M” stands for “Master” for a reason. There can not be 2 DMR’s for the same device in 2 different factories.

Has anyone had a similar issue? How did you handle it?
 
Elsmar Forum Sponsor
#2
If you look at the requirements for the DMR, you will see that it contains all the information used to manufacture the part. So the DMR will specific to the part and to the manufacturing location. Your Ireland plant needs prints, work instructions, inspection sheets, etc to make the part. Because they need documents to make the part, they need their own DMR.
 
B

bkabitz

#3
Thanks Dave,

My concern is that the DMR is being maitained in 2 locations which seems like a problem waiting to happen. I'm not sure what the solution is, but I would like to reduce our exposure to documentation errors, and unnecessary paperwork.

Bill
 
#4
I don't think it is as big of a problem as you might think. All of the product information (such as prints, bill of material, etc) need to be identical of course, but there could easily be process documents that vary from location to location. Differences could be due to various equipment type and ages, as well as local requirements for inspections, material certs, etc.
 

yodon

Staff member
Super Moderator
#5
I kind of agree with Dave B but have a somewhat different take. The DMR doesn't need to contain the items maintained at either site; only needs to reference / identify them. Some sort of cooperative effort, though does need to be established. Maybe divide up the DMR into parts that the design center keeps / is responsible for and the parts that the manufacturing center keeps / is responsible for. At some point they need to come together to establish *THE* DMR for a particular build.

What I do is just have the DMR as an index. I also version the DMR so if build x uses one set of revisions of drawings / manufacturing instructions and build y uses a different set, I can always tell the difference.

Like Dave B does say, it's not (shouldn't be) a big problem as long as the lines of responsibility are clear and an overarching management approach is established.
 
B

beyedoers

#6
Cautiom: ensure the labeing and packaging specs are respected in case the distributed product are identical in design. One possibility to ensure consistency is both sites utilize shared IT configuration management system. Good luck!
 
M

MIREGMGR

#7
There can not be 2 DMR’s for the same device in 2 different factories.
They are maintaining a DMR in Ireland for all the devices they are manufacturing, is this necessary?
There is only one DMR, for which the specification provider (not the contract manufacturer) is responsible. However, it's permissible for the DMR to be distributed. Master records and documents can be kept at two or more locations, as long as appropriate controls are maintained. If particular required information is kept at both locations for operational convenience, you must establish and maintain clarity via the applicable controls as to which is the master version of a particular required item of information, and which is a dependent copy.

In your case, since the contract manufacturing site in theory is not participating in design, it might be hard to justify to FDA why their version of an item of DMR information was the master and yours was dependent.

They on the other hand might maintain the master version of the DHR, i.e. the production records.
 
V

VickyME

#8
Hello Everyone,:bigwave:

I am a Design Engineer in a startup medical device company, i have been assigned the responsibility of creating a Device Master Record. In most of the articles i see a complete set of DMR documents to be referred.

But our problem is, we only design and develop the device and we have our contract manufaturers for manufacturing after design freez. The DMR index i have created is attached herewith. The confusion is that i dont have any controlled document for the manufacturing what they use for them like equipment maintainance procedures, blank work forms , etc. So should i have to include them too in our DMR??
Thank you in advance!!
:thanx:
 

Attachments

pbojsen

Involved In Discussions
#9
The DMR can be distributed, i.e. you would have some of the DMR info, and the contract manufacturer would also have some of the info.

You = Design History File, Drawings, BOM, component/subassy specs, labeling, IFUs, shelf life, sterilization, etc. Do you inspect the devices? If so, you would have those inspection document numbers listed if you have an "index" type of DMR.

Contract Mfg = Manufacturing procedures, some sort of reference to the design documents they received from your company, Inspection procedures, testing procedures, etc.

You, as the designer, would do "design transfer" of many of the documents to the CM, and the CM would take those documents and (in most companies) keep that information in a product file, and transfer that information into their documentation system, i.e. their own drawing numbers, part numbers, etc. As a contract manufacturer, sometimes we dictated the manufacturing procedures, and sometimes they were dictated to us and we had to provide the manufacturing specs to the Spec Developer (design house). If those docs changed, then the Spec Developer also had to sign off on the change order.

You need design control.
You need supplier change control, i.e. the changes that your supplier wants to make should be approved by your company before they make any changes to your product.

Things like equipment maintenance should be covered in your audit or inspection of their site in your supplier approval SOPs. Your supplier "should" have a QMS as well that addresses design transfer, change control, etc.

This is not a comprehensive answer, but should get you further down the road.
 
Last edited:
Thread starter Similar threads Forum Replies Date
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sam Lazzara Medical Device File (MDF per 13485:2016 4.2.3) versus FDA Device Master Record (DMR) ISO 13485:2016 - Medical Device Quality Management Systems 3
R Are DMR (device master record) and DHR (device history record) inspected by FDA or audited by an NB ISO 13485:2016 - Medical Device Quality Management Systems 6
S Foreign Manufacturer and DMR - Who keeps the DMR (Device Master Record)? ISO 13485:2016 - Medical Device Quality Management Systems 2
S DMR (Device Master Record) for Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 3
I DMR (Device Master Records) and similar for standalone software device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S DMR (Device Master Record) Management and Index questions Other US Medical Device Regulations 18
P DMR (Device Master Record) for Class I and Class II Dental Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C When to submit a 510(k)? After the DMR (Device Master Record) is finished? Other US Medical Device Regulations 4
J Contents of DMR (Device Master Record) when manufacturing is by 3rd party 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A DMR (Device Master Record): What is meant by these words - Software Specifications? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
D DMR (Device Master Record) Index as a Controlled Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
E Need help establishing a DMR (Device Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 50
B Format of Device Master Record (DMR) for Combination Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Device Master Record (DMR) that was compiled by another company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
W Update DHF (Device History Record) when DMR (Device Master Record) changes? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
W DMR (Device Master Record) Revision Requirements? FDA GMP Manual 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S DMR Index - Can someone share their Device Master Record Index structure or format? ISO 13485:2016 - Medical Device Quality Management Systems 15
M DMR - Device Master Records - What is the best way to structure the DMR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 55
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
S Quality Plan at a small Medical Device Company - Is the quality plan a DMR document ISO 13485:2016 - Medical Device Quality Management Systems 6
M Merge Technical File, DMR, and Device File into a single document? Other Medical Device and Orthopedic Related Topics 3
M Medical Device DMR's - List of the Marketing or Market Penetration documents ISO 13485:2016 - Medical Device Quality Management Systems 14
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
P DHF, DMR and DHR in MDR? EU Medical Device Regulations 6
R DMR or Manufacturing Documentation - How detailed does the documentation have to be? ISO 13485:2016 - Medical Device Quality Management Systems 1
D Design Outputs vs DMR (Design Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Is an index necessary for DMR or DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
V What is required in terms of the DHR, DMR, DHF? Other Medical Device and Orthopedic Related Topics 4
S Difference between DMR procedures vs. QMS procedures? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q DMR and DHR - Two requirements, One Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Incoming Inspection Plans under Design Control (part of DMR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
O Distributors and ISO 13485 - DHF and DMR Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 7
U Document Revisions Required in DMR Index? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
J Referencing the DMR (Design Master Record) in the PO Document Control Systems, Procedures, Forms and Templates 2
C Do I need to show fasteners in my BOM's/DMR etc? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
C Re-Verification of Nonconforming Product prior to closing our DMR AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
T Manufacturing Process Deviation linked to DMR (Discrepant Material Report)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Format for Discrepant Material Report (DMR) - Nonconformance Report (NCR) Document Control Systems, Procedures, Forms and Templates 1
S What do we need for a DMR? Importer of Record and Going Crazy! 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D What kind of DMR must a Medical Importer have? Other Medical Device and Orthopedic Related Topics 8
B Dealing with Outsourced Processes in a DMR ISO 13485:2016 - Medical Device Quality Management Systems 7
J Which supplies/suppliers need to be listed in DMR? ISO 13485:2016 - Medical Device Quality Management Systems 4
V Medical Products: CE Marking - Are the DMR's, Technical Files, DHF, required? EU Medical Device Regulations 6
C Technical Documentation, DMR, ISO 13485 vs. FDA, STED Document Control Systems, Procedures, Forms and Templates 10
C Structure and Content of DMR / Technical Documentation (FDA vs. ISO 13485)? Document Control Systems, Procedures, Forms and Templates 6
T DMR/DHF/DHR/Batch Records/Master Batch Records ISO 13485:2016 - Medical Device Quality Management Systems 3
M What Marketing/Market Penetration information should go on the DMR? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom