Product Level Software Risk Management Plan and Report

#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.
 
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Ronen E

Problem Solver
Staff member
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

Staff member
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]".
 
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