RE: ISO 13485
- From
Jason Pyeron <jpyeron@pdinc.us>
- Date
- Jun 17, 2014, 15:30 UTC
- Message-ID
- <0368137BF4DA4E798A17D74DAFE30FEF@black>
- In-Reply-To
- <53A05766.7060502@omixon.com>
Show 13 quoted lines
> -----Original Message----- > From: agi > Sent: Tuesday, June 17, 2014 10:58 > > Hi Jason, > > Thanks for the speedy reply. We are in the process of trying > to make our > software product ISO13485 compatible and we are assessing all systems > that we use. > Do you have a validation document for git that could provide > information > on how to use it in order to comply with ISO legislations?
That would be customized to your QA process. A generalized document would be too vague. I am sure any process consultant could draft that up for you. (disclaimer: I have been paid to do things like this before)
Maybe you could start by searching with things like https://www.google.com/search?q=using+QA+with+Git or contacting Atlassian about their QA product suite integration with Git.
Maybe you could find a process consultant to do it cheaper if you release it out to the FOSS community?
The "nice" (read as less effort) thing about ISO 13485 is it does not have a continual improvement requirement so as long as "defects" are detected and remediated you are good. Please note git does not detect defects, git does not remediate defects. What git does is ensure the approved artifact is unchanged in any attribute to maintain the exact level of quality from first inspection of that artifact for an unlimited amount of iterations. Git has built in "digital signatures" on the artifacts stored in its repository.
Show 29 quoted lines
> Any additional information or material you can think of is more than > welcome. > > Thanks in advance for your help! > > > Best Regards, > Agnes Pasztor > > Senior Test Engineer > Omixon Biocomputing Ltd. > > > On 06/16/2014 05:20 PM, Jason Pyeron wrote: > >> -----Original Message----- > >> From: agi > >> Sent: Monday, June 16, 2014 11:14 > >> > >> Hello, > >> > >> I would like to ask a question about GIT v. 1.7 > >> > >> Is it compatible with ISO 13485 (quality management system)? > >> Can it be > >> used for developing a medical diagnostic software? > > Yes. > > > > Now, do you have a specific question about how to use Git > in your QA process?
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