Product Level Software Risk Management Plan and Report

U

ujain82

#1
I have written a Software risk management plan which is at a product level. What happens when there is a maintainence release on this product? Do i have to reference/leverage Product RMP or write a new project specific risk management plan for small bug release of a product.

Similar question for Risk management report. Should i be writting the report for each release of the product until the product retires?

I assume all activity goes into the Risk management file. I wanted to know the criteria for RMP and RMR.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
I have written a Software risk management plan which is at a product level. What happens when there is a maintainence release on this product? Do i have to reference/leverage Product RMP or write a new project specific risk management plan for small bug release of a product.

Similar question for Risk management report. Should i be writting the report for each release of the product until the product retires?

I assume all activity goes into the Risk management file. I wanted to know the criteria for RMP and RMR.
Hi,

As a general approach, I'd say that every time you introduce a change to a released device you should revisit the RMF, and either update any and all relevant sections (you could reissue documents as appropriate); or formally document a rationale why the former is not required / applicable. the latter could be captured either in the RMF itself or in the technical change records (e.g. DHF etc.). The important thing is that such justification would be readily accessible to you and to any future reviewer / auditor.

Cheers,
Ronen.
 

Peter Selvey

Leader
Super Moderator
#3
When an existing medical device is updated, even for a simple bug fix, it creates new configuration and a new medical device, even if the sales name stays the same.

This new device needs to have its own unique set of regulatory documents.

Of course, that set may include many or most of the documents for the previous version, if they remain valid (representative) of the new version.

But as a minimum, at least a plan and release report is needed which is created new for the new configuration. Both the plan and release report need to include requirements from regulatory standards such as ISO 14971, ISO 13485, IEC 60601-1/PEMS, IEC 62304 and so on.

In practice, it is best to have a single plan which incorporates all the requirements from various standards as well as the normal stuff in a design plan (for example, scope of design or change, who will do it, expect cost, responsible persons, due date etc etc). Similarly, there can be a single report authorizing release of the product which includes all requirements from practical side as well as the requirements from standards.

And for a simple bug fix with little impact to safety, these can be heavily simplified. For example, to cover risk management, the release report could just have a check point that says "The risk management file remains valid for the current configuration: [Y] / [N]".
 
Thread starter Similar threads Forum Replies Date
A Level of details required for Class IIb Product Verification and Validation CE Marking (Conformité Européene) / CB Scheme 1
V AQL for Component Level and Assembled Finished Product AQL - Acceptable Quality Level 1
H 87% Confidence Level for the Product Quality Control for Various Products Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
N Extent of Product Traceability Required by ISO 13485 (Low Level Class I Devices) ISO 13485:2016 - Medical Device Quality Management Systems 3
E AQL Level Change for FDA Validated Unclassified Dental Product Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
I Calculating Quality Level for a Product - Small Batch Manufacturing Quality Tools, Improvement and Analysis 9
apestate Custom hardware product - What acceptable quality level (AQL) is expected in the US? AQL - Acceptable Quality Level 4
N Brexit Combination Product Regulatory pathway for UK (MHRA). UK Medical Device Regulations 0
M Process Flow of ECN Product User and Service Guides Process Maps, Process Mapping and Turtle Diagrams 1
M Product Labeling EU Medical Device Regulations 11
F Supplier : Product Qualification Supplier Quality Assurance and other Supplier Issues 0
F IEC 60601-2-54:2009 Accuracy of CURRENT TIME PRODUCT IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Adding new product code/Catalogue number to existing 510K US Medical Device Regulations 0
G Scratched tubing to be treated as nonconforming product? Manufacturing and Related Processes 10
A Production for same product at two production sites AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Art 117 product classification under rule 5 EU Medical Device Regulations 0
M Teeth Whitening Product Classification Canada Medical Device Regulations 0
M Safety assessment of cosmetic product EU Medical Device Regulations 1
H EMC & Safety Testing of the product with the same Sr. No. for EC Declaration CE Marking (Conformité Européene) / CB Scheme 3
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
D Digital Product Definitions Related Work Instructions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
V Would the customer drawing change necessitate re-PPAP of the Product? APQP and PPAP 3
A Combination product Canada Medical Device Regulations 3
E UDI on product/packaging levels EU Medical Device Regulations 8
M Drug-Device Combination product CE Marking (Conformité Européene) / CB Scheme 1
H Product Safety & Conformity Representative (PSCR) Training Company IATF 16949 - Automotive Quality Systems Standard 0
X Design stage overview (Product specification) EU Medical Device Regulations 3
9 Responsibility for Product Paid for but not yet Shipped AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Product Acceptance Software (PAS) PROCEDURE (BOEING D6-51991) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Combo Product Assembly Process OQ Qualification and Validation (including 21 CFR Part 11) 0
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
A Product Liability Insurance coverage for EU Importer by UK Manufacturer EU Medical Device Regulations 2
sonflowerinwales Outgassing - product inside a sealed housing Manufacturing and Related Processes 1
L Temporary Product Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
FRA 2 FDA Product NCRs- Quality Review Nonconformance and Corrective Action 6
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Aftermarket product PPAP approval IATF 16949 - Automotive Quality Systems Standard 1
G How to find applicable standards for a new product? EU Medical Device Regulations 6
T Link GMDN code and FDA product code US Medical Device Regulations 5
S Combination Product - Packaging US Food and Drug Administration (FDA) 6
S Can a product option change the product class? CE Marking (Conformité Européene) / CB Scheme 2
H Regarding EMC & Safety retesting requirements of the product CE Marking (Conformité Européene) / CB Scheme 2
Q Product audit assessment IATF 16949 - Automotive Quality Systems Standard 4
S Submit under a new product code in a 510k? US Medical Device Regulations 5
P Product Quality Review API-GMP Manufacturing and Related Processes 0
D Shelf life of non sterile class IIb product. ISO 13485:2016 - Medical Device Quality Management Systems 1
A Product Update and executing only affected System Tests, leaving out unaffected ones IEC 62304 - Medical Device Software Life Cycle Processes 5
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
J Enough for PSUR to cover product family? (Procedure packs, not the legal manufacturer) EU Medical Device Regulations 1

Similar threads

Top Bottom