DMR (Device Master Records) and similar for standalone software device

#1
Hi everyone,

I was hoping I could get some help in understanding how to set up the DMR for a standalone software which is class II. I am having a little trouble breaking it down with respect to all the other record files required (DHR,DHF, and QSR). Can you provide examples that relate to software development as opposed to component or product manufacturing?

Any and all templates/examples would be a huge help!
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
Re: DMR and similar for standalone software device

I'll start with a high-level description and use references to IEC62304.
DHF will be all documentation from section 5. Software Development Process and section 7.
DHR will be information you generate, or reference based on requirements from section 5.8 - Software Release. This applies to the initial release as well as future releases to fix bugs or add new features and improvements.
DMR will be the code itself. One could argue that Software requirements and design specs are also part of the DMR. DMR is the recipe or a blueprint for your product. Imagine you want to go to Mars and want the Martians to replicate your software; DMR contains all the information needed to recreate the software without the historical information of how the software was developed.

If you provide your software on media, e.g. ship on a CD, then all files will also include information related to replication and distribution of the media.

QSR (Quality System Regulation) is not a file type but an equivalent of a Quality Management System. One of the sub-systems is the Design Control, which is directly applicable to the software development activities.

Let me know if this helps or if you have further questions.

--
 

yodon

Staff member
Super Moderator
#3
Re: DMR and similar for standalone software device

Generally in agreement with mihzago but I wouldn't go so far as to cite the requirements or design specs in the DMR. The DMR is a blueprint to "manufacture" your product and so for software, this could include the build process but certainly would include the processes to install and verify installation of the software. As mihzago does mention, if you distribute on CD / DVD / flash drive, then the process for loading the media and ensuring everything is included (and correct and complete) is part of the DMR.
 
Thread starter Similar threads Forum Replies Date
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
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
B DMR (Device Master Record) For Contract Manufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
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
sardonyx 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 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
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
S FDA expectation of Concessions - Changes to a DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
M DMR, DHR and DHF physical form 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V Examples of Defective Material Reports (DMR) Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom