DMR (Device Master Record): What is meant by these words - Software Specifications?

Aphel

Involved In Discussions
#1
Hello all,

I have a short question.

You know, §820.181(a) describes device specifiactions. From my point of view everything is clear in this section - exept the term with "software specifiactions".

What is meant by these words? What are "device software specifiactions" exactly - are they the documented and approved "software code" or something else?

Thank you very much for your support.
Best regards,
Aphel
 
Elsmar Forum Sponsor
#2

Aphel

Involved In Discussions
#3
Re: DMR: What is meant by these words - Software Specifications?

Hello,

What type of SW specification now is a DMR acc. to §820.181 -> i) or ii)?

bg, Aphel
 

Aphel

Involved In Discussions
#4
Re: DMR: What is meant by these words - Software Specifications?

Hello,

Can no one help answere the question regarding DMR?

What do you show as part of DMR to an inspector when we are talking about
software specifications?

Is it the embedded SW and its specifications - so the SW code?
Is it the SW necessary to manufacture and test the device?
Is it something else?

Again - many thanks in advance for your support.

Best regards,
Aphel
 
P

pldey42

#5
Re: DMR (Device Master Record): What is meant by these words - Software Specification

I don't know about medical devices specifically but generally, in the software industry, the process is (or should be) something like:

  • define customer requirements for a machine
  • define architecture for the machine
  • allocate requirements to architectural components, e.g. heart rate will be monitored with transducer connected to microcomputer
  • allocate requirements within the computer to hardware/software elements (e.g. in some designs there might be hardware that counts heartbeats and sends a count to the software; in others there might be a signal to the software for each heartbeat, so the software has to do the counting)
From all this comes a specification for the software telling the software engineers what the software should do and referring to the relevant hardware specs telling them what the computer and I/O hardware will do. It will specify features, functions, critical algorithms, I/O parameters, performance criteria, size and speed of target computer and so forth. The spec is typically one or several documents, mixed text and diagrams. It's the software equivalent of a drawing.

The software engineers write the code, then inspect and test it against the specifications to make sure it's what was asked for.

Experienced software engineers understand that many bugs are due to specification and design errors, as well as errors in coding (coding being the activity of translating the design into programming language that the machine can understand). This is why your inspectors want to see the specs as well as the code.

If I were inspecting such a device then, as an experienced software engineer, I would ask to see the specifications and records of their review, I might ask for samples of the code itself (to inspect code quality for myself), and I would certainly ask for records of code inspections (because tests cannot reveal all the bugs and in safety-critical applications: code inspections are a vital method of spotting certain errors that will slip through tests). I'd ask for test specifications and records of their review against the software specifications, and for test records. I'd finally ask for validation records - tests with users to assure the software works and hopefully detect any errors in the specifications themselves. I would also interview the software engineers, being mistrustful of records, to assure that the records are an accurate reflection of the real work.

Hope this helps,
Pat
 
#6
Re: DMR: What is meant by these words - Software Specifications?

What do you show as part of DMR to an inspector when we are talking about
software specifications?

Is it the embedded SW and its specifications - so the SW code?
Is it the SW necessary to manufacture and test the device?
820.181 said:
Sec. 820.181 Device master record.

Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:

(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d) Packaging and labeling specifications, including methods and processes used; and

(e) Installation, maintenance, and servicing procedures and methods.
So requirement A is for the specifications of the device, including specifications of embedded software.

Requirement B covers specifications of production software.

For details of what should be included in those specifications check the FDA guidance document in my previous post.
 
P

pldey42

#7
Re: DMR (Device Master Record): What is meant by these words - Software Specification

Just for clarity, I take it that "production software" is the software tooling that is used to burn the software that will be embedded into the PROMs. It needs to be checked, as well as the embedded software itself, to assure that the burn process is accurate.
 

yodon

Staff member
Super Moderator
#8
Re: DMR (Device Master Record): What is meant by these words - Software Specification

Generally good information so far. I don't know if your question as related to the DMR has been answered yet.

The DMR is the "recipe" for how the product is manufactured. The QSR specifically notes that software specifications are to be included. As pointed out in previous posts, this can include (references to) requirements specs, design specs, etc.

The QSR goes on to talk about more 'hardware-centric' items. But there are certainly some important items to consider for software. I'm just brainstorming here so this isn't necessarily a comprehensive list but consider it a starter:

- Presuming you have the software under change/version control (and PLEASE say you do!!), a snapshot of the configuration at the time of build (typically companies tag each module (version) in the build at the time of the build).

- While probably binaries (executables) are provided to production, the build procedure could be considered for identification. This might even include an identification of the build environment (compiler version, etc.).

- Identification of any equipment and instructions on how to install the software. If not embedded, you'd probably want to identify any installation parameters and dependencies (OSs (and versions), DB (versions), browsers (and versions) supported, etc.). If there are other aspects to the installation, such as setting up databases or installing support libraries, these would be detailed. If embedded, the equipment and procedures to burn or load. If there might be options as to, say, board levels supported (or not supported), these could be specified.

- Any instructions for ensuring the software (and data) is installed properly. For example, there may be a CRC that can be used to confirm the 'bits' are correct. There may be a procedure to run to ensure it's operational.

- If there are procedures to set up the software specific for a site, these should be referenced.

- If there are User's Guides, Management Guides, User Configuration Guides, etc., delivered with the software these should be referenced.

- If you're maybe burning software onto a CD or DVD for delivery to the customer, the burn procedures (and as I mentioned above, CRC checks to confirm the right bits are burned), labeling procedures, etc. should be identified.

That's all I can think of at the moment. And besides, the post is getting rather long. Hope it helps.
 

c.mitch

Quite Involved in Discussions
#9
Re: DMR (Device Master Record): What is meant by these words - Software Specification

DMR for software is a set of documents, which prove that it was designed according to the state of the art. It contains:
-a development plan (the organization and the project)
-some input data, like user requirements (how it works)
-a risk analysis (risks linked to soft)
-software specifications (how it works technically)
-software architecture and conception (very technical docs made by soft engineers, ... and usually only readable by them!)
-software tests procedures and tests reports (does it work like expected)
-and software version description (the version of soft + what it needs to run + how it is installed + remaining issues if any)

IEC 62304 is the standard about software in medical devices. It is recognized by FDA and harmonized by EU. It describes what the content of a soft DMR should be.

See http://www.emdt.co.uk/article/developing-medical-device-software-iso-62304 or http://blog.cm-dm.com/post/2011/11/18/Software-Medical-Devices.-How-to-obtain-market-homologation for more info.

Mitch.
 

yodon

Staff member
Super Moderator
#10
Re: DMR (Device Master Record): What is meant by these words - Software Specification

DMR for software is a set of documents, which prove that it was designed according to the state of the art. It contains:
Mitch, I would respectfully disagree somewhat with the above statement. While those documents you list are certainly by-products of standard, state-of-the-art software design practices, I believe design artifacts belong in the DHF. Some of those (specifications, risk, VDD) may be applicable to the DMR but I don't see the test protocols / results as applicable.

I think it's important to recognize the distinction between the DHF and the DMR.
 
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
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
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