Device Master Record

nehalmahajan55 · May 15, 2024

I have created first draft of the DMR on the device which my organization is working on, I have attached it below. I was hoping if all the viewers could review it once and guide me for necessary changes, As it is my first time working on it, there are few items blank which i am still working on.

Thankyou all in advance

indubioush · May 16, 2024

It looks to me like you are going down the wrong path here. The DMR typically references specification documents and QMS procedures. For example, if your device was made of two plastic pieces assembled together, your DMR would reference the specification number of the first plastic piece, the specification number of the second plastic piece, and the manufacturing procedures for assembly and test. If you were to show me the specification document for the first plastic piece. It would have all information on the material, dimensions, how to inspect it, etc. Basically all the info would be there that you could provide this drawing to a molding house, and they could make it for you. The DMR is the recipe of the device and through the DMR, there should be a connection on every detail on how to make it.

What you have looks more like design inputs and design input requirements. These are critical elements of design control. Contrast this to DMR items, which are critical elements of manufacturing production.

Ed Panek · May 16, 2024

This looks like a high level Design Plan. Thats a requirement of FDA so that's good.

This is a scrubbed version of our DMR

Purpose

Document the identity and location of the compilation of records containing the procedures and specifications for the XXX Medical Device

Device Master Record (DMR) Index

Document Type	Document Number(s)	Document Location
Device Specifications
Traceability Matrix	TM-TTC01	Where this record resides
Master Bill of Materials (BOM)	MBOM XXX 01 MBOM XXX 02 Etc etc	Where this record resides
Engineering Drawings Components Subassemblies Assembled Devices	Refer to the Master Bills of Materials (MBOMs) for lists	Where this record resides
Software Specifications
Software Traceability Matrix Software Requirement Specification (SRS)	TM-TTC01 Note: SRS is embedded in the Trace Matrix	Where this record resides
Production Process Specifications
Equipment Specifications
Commissioning Reports	Refer to XXX Verification Records	Where this record resides
Validation Reports	Refer to XXX Validation Records	Where this record resides

Production Methods
Process Sheets (Manufacturing Routings)	Refer to XXXs Standard Operating Procedures, Work Instructions, and Forms
Manufacturing Detail Sheets (Inspection Plan and Tooling & Set-up Instructions)	Refer to XXXs Standard Operating Procedures, Work Instructions, and Forms
Production Procedures
Assembly Process documents	Refer to XXX Work Instructions and Forms
Production Work Instruction Index	Refer to XXX QSR
Production Record	Refer to XXX DHR
Production Environmental Specifications
Process Control Procedure	Refer to BST’s Production SOPs

Quality Assurance Procedures, Specifications, and Equipment
Receiving Inspection criteria for purchased parts
Manufacturing Detail Sheets for fabricated parts (Inspection Plan and Tooling & Set-up Instructions)	Refer to XXX production SOPs and XXX Drawings
QA Work Instructions (as applicable)	Refer to XXXs SOPs
Packaging and Label Specifications
Packaging Specification	XXX-MODEL-100
Labeling Specifications	Refer to Engineering Drawings
Lot Code Specification	LOT CONTROL SOP

Additional Information:

The XXX product is not intended to be installed, maintained, or serviced – therefore no installation, maintenance, or servicing procedures and methods are included in the DMR.

Device Master Record

nehalmahajan55

Starting to get Involved

Attachments

indubioush

Ah ha!

Ed Panek

QA RA Small Med Dev Company

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