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IEC 62304 Software Development Plan

A

AOIRA

#1
Does anyone have a IEC 62304 software development plan to share? I am currently addressing the deficiencies we received for our 510(k) submission. I purchased wonderful templates for configuration management and software maintenance from SEPT, but they are useless without the development plan. Thanks!

David S.
 
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D

danpa

#2
Do you have a defined and documented development process? You must if you are following the QSR. In this case you have the majority of the software development plan already done. The development procedures are the core of your plan. The Plan document is then the information that has not been proceduralized such as, what the project's goals are, what functionality is to be included in the project, the actual development project schedule, where documents will be stored, who is involved (often part of the schedule as well), what testing will be done, etc. I view plans as containing the information needed by the team to complete the project successfully from an administrative point of view. The plan document should be useful to the development team - it should give them information and save them from having to make "process/procedural" decisions.

62403 is written from the perspective of not requiring documented procedures. If you don't have a documented procedure for development, then the plan needs to lay out all the information that a development procedure would discuss.
 
A

AOIRA

#3
Thanks danpa. We do have a documented development process, but it is so top level that I didn't bother to look at it and see that all we needed for the software dev plan were project-specific items, as you wrote. Best Regards.

David S.
 
A

AOIRA

#4
I put together a software development plan in accordance with IEC 62304. It is the highest level document for the development program that we are currently establishing (for now, as a policy will follow). Don't confuse it for a plan to be used by engineers and programmers. We have a very long way to go before we get to that point. To that end, you may not find it very useful.
 

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G

goldstar

#5
Well, I don't have much experience with IEC 62304 Software Development Plan, after reading your post it seems good .
 
A

alicecbrown

#6
Hi, I"m new to this forum, but I really need to get a copy of IEC 62304.
Where could I just look at it without getting stiffed for $232.?:mad:
 

Stijloor

Staff member
Super Moderator
#7
Hi, I"m new to this forum, but I really need to get a copy of IEC 62304.
Where could I just look at it without getting stiffed for $232.?:mad:
Depending on where you live, you may try the library at a university...

Otherwise, consider it cost of doing business....;)

Stijloor.
 

sagai

Quite Involved in Discussions
#10
Ah, that checklist is not accurate... was it written for an old version of the standard?
ie, both the reference numbers and the class definitions are sometimes incorrect.
You are right. Thank you for reminding, i have no idea how it could be, but this sheet shall be reviewed.
br
Sz.
 
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