IEC 62304 Software Development Plan

B

brenhale

#11
Going back to the original post in this topic, does anyone have a development plan that they wish to share? ie, to quote another entry, one that "The plan document should be useful to the development team"

The one plan that was submitted earlier in this post is very high level, so much so that it is almost the same level as the standard itself...
In the case of a company using one generic plan template across their projects (ie, not developing plans/processes per project), then something a lot more detailed would be required.
 
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sagai

Quite Involved in Discussions
#12
Going back to the original post in this topic, does anyone have a development plan that they wish to share? ie, to quote another entry, one that "The plan document should be useful to the development team"

The one plan that was submitted earlier in this post is very high level, so much so that it is almost the same level as the standard itself...
In the case of a company using one generic plan template across their projects (ie, not developing plans/processes per project), then something a lot more detailed would be required.
Yes, this is what the Company has to develop and we call as the Implementation of the 62604 standard.

Seriously ... the detailed Development Lifecycle Procedure level description DOES depend on the Company, its Medical Device Classification, its ruling mandantory notified body, its Development Approach (Agile, XP, Waterfall), its organizational structure, etc.

And not for the last these documents are highly confidential, due to the fact they tells you how the processes are/shall work/ing at the Customer Site.

If you can tell as more details, we may can give detailed ideas.

br
Sz.
 

sagai

Quite Involved in Discussions
#13
Yes, this is what the Company has to develop and we call as the Implementation of the 62604 standard.

Seriously ... the detailed Development Lifecycle Procedure level description DOES depend on the Company, its Medical Device Classification, its ruling mandantory notified body, its Development Approach (Agile, XP, Waterfall), its organizational structure, etc.

And not for the last these documents are highly confidential, due to the fact they tells you how the processes are/shall work/ing at the Customer Site.

If you can tell as more details, we may can give detailed ideas.

br
Sz.

62304, anyway
 

sagai

Quite Involved in Discussions
#17
Well, the Development Plan telling what is your activity plan for the software till and after put into the market, so its content very much depends on the detail of your recent QMS.
The SRS is much depends on your implemented Risk Management process, so the obvious tabular content are ID, description, safety "link", SDS "link", IQ/OQ/PQ classification, but again, the SRS also very much depends on the lifecycle methodology you follow. For example if you use waterfall, than you have to have different requirement engineering structure than the one is efficient in scrum.

I would suggest to create the template of these documents based on your software lifecycle model, your device classification and the related requirement defined in device controll and in IEC62304/ISO14971/IEC62366 .

I know, you would be more happy to have a template downloaded, but you only would bind your development team to a heavy stone.

Regards
Szabolcs
 
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