DMR (Device Master Record) for Medical Device Software

S

sarkalgud

#1
Do we necessarily have a DMR for Medical Device Software? What is listed in a software DMR?

Thanks!
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
You mean Software as Medical Device (when the software itself is the device)?

If so, you need to have design and development, and manufacturing information, generally. A DMR is required by the FDA regulations, others do not required a file called DMR (but all of them require that you have the "recipe"to manufacture the device, which is basically what the DMR does).
 

yodon

Staff member
Super Moderator
#3
I've struggled with this as well.

While a specific DMR is required under the FDA regs, there's a bit of a similar requirement in 13485 to have 'documentation of procedures and methods for the control of production.'

Still, not all that well obvious for software.

Software "production" starts with the build then the binaries should be put somewhere for control and whatever distribution is done. Unless delivered as a service, there's installation matters to consider and maybe verification of installation (e.g., checksum). All of these *could* be considered as fodder for DMR / documentation of procedures and methods for control of production.

Just some food for thought. Hopefully others will contribute with what they've done / experiences they've had.
 
B

BhupinderSinghPawa

#4
For Software the Device Master Record includes the Software Binary and Software Release Notes. The Software Release Notes specifies the location of the binary - that can be a shared network drive or USB drive or CD-ROM; and also includes instructions to install the software and verify that installation is correct. As applicable, additional test instructions (in validated simulation environment) as part of in-process or final quality check to confirm that software is working correctly, is included in DMR. So that's the production specification that Engineering hands over to Manufacturing/Production for software.
 
Thread starter Similar threads Forum Replies Date
D Device Master Record (DMR) checklist ISO 13485:2016 - Medical Device Quality Management Systems 1
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
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 9
S Foreign Manufacturer and DMR - Who keeps the DMR (Device Master Record)? ISO 13485:2016 - Medical Device Quality Management Systems 2
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
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) 62
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

Similar threads

Top Bottom