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Software Validation – Clause 4.1.6 of ISO 13485:2016 - Page 2


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iso 13485 - medical device qms, iso 13485:2016, mdd 93/42/eec, software validation
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  Post Number #9  
Old 22nd August 2017, 06:47 AM
MC Eistee

 
 
Total Posts: 4
Re: Software Validation – Clause 4.1.6 of ISO 13485:2016

Since you wrote excel macros you must have had requirements for that.
So a good start would be writing them down.
Do not take excel into consideration. Just your requirements for that specific case. Using Excel is just a way to achive that.

When you wrote your requirements down you have your requirements / software specification.
Do a risk assessment on your requirements. You might link them for traceability purposes.
Your risk assessment indicates what kind of actions are necessary based on the overall risk of a specific requirement not fulfilling its purpose.
Then you should write test cases. What is your interaction with the excel tool to test a requirement. That is what should be document. When you are done with that you can actually start to test you excel tool. Do not forget to collect objective evidence. And there should be a final approval.

Do not forget to document and approve all your actions.

Hope that might help a bit getting started.
Thank You to MC Eistee for your informative Post and/or Attachment!

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  Post Number #10  
Old 22nd August 2017, 08:44 AM
WilBryan

 
 
Total Posts: 32
Re: Software Validation – Clause 4.1.6 of ISO 13485:2016

That is a really well written approach. thanks for the great advice!
We have a lot of this information but formalizing it as an approach to meet the validation requirements is the link we were missing.

Sincere appreciation MC!
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