IEC 62304 Clause 6. Medical Device Software Maintenance Plan

[sl344]

in IEC62304 clause 6, it states that a software maintenance plan should be established. My question is, if we have the process already defined in the company general SOP how to handle post release issues, do we still have to have a separate software maintenance plan particularly for the software if we claim that we are IEC32604 compliance? thanks!

 

[glork98]

in IEC62304 clause 6, it states that a software maintenance plan should be established. My question is, if we have the process already defined in the company general SOP how to handle post release issues, do we still have to have a separate software maintenance plan particularly for the software if we claim that we are IEC32604 compliance? thanks!

I'd say "yes."

The rest of your companies procedures make the job easy. Put together the boilerplate and reference the other procedures for issue tracking (CAPA) and dovetail that with the product development mechanisms you'll apply to the discrepancies you choose to fix.

Not a lot of pages in any case.

 

[sl344]

Thanks a lot for your reply. I will draft one for it.

 

[Sravan Manchikanti]

Dear Elsmar fiends,

I would like to extend this tread for getting more inputs on integrating IEC 62304 requirements in to implementation of ISO 13485 for a SaMD product.

When I read IEC 62304, Section 6 Software Maintenance looks like 8.2.1 Feedback & 8.2.2 Complaint handling of the ISO 13485 (More of Post market compliance). With this understanding, can we say,

Software Maintenance Plan ~ Post Market Surveillance Plan

I mean, can we refer PMS plan while fulfilling the IEC 62304 compliance of Section 6 Software Maintenance ?

Appreciate your views.

Thank you,
Sravan

 

[yodon]

One major intent of the Maintenance Plan is to use the data to feed back into your software development process for improvement. You may find there are trends in issues reported that can be addressed in improvements in design or test. Also, 62304 recognizes the 'soft' aspect of software - it CAN be updated periodically, unlike changing hardware components.

I typically have separate SW Maintenance Plans and PMS Plans. Certainly the PMS data gathered can feed into the SW Maintenance work. And bear in mind that the stakeholders for the Plans are different.

 

[Sravan Manchikanti]

Dear Yodon,

Thanks for your quick input.

I am asking particularly in the case of SaMD (by a start-up) where there wouldn't be any hardware components and the critical feedback might always push for an improvements in design or test. I feel there is a lot of redundancy when we keep 2 separate plans. Can we do that kind of customization for a small company where the stakeholders for the both Plans are possibly same?

Of course, we can provide references to key supporting process like Feedback & Compliant handling (Problem Resolution), Change management, Risk management & Configuration management ?

 

[yodon]

Sure, there's nothing that dictates how you do things. If it's efficient and effective to cover both PMS and SW Maintenance in one plan for you, then by all means. Just be sure you cover everything, of course.

 

[Sravan Manchikanti]

Thank you Yodon!