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Custom software services to be used by medical software

#1
Hi,

My company is trying a new approach to create small services that can be used by multiple medical\non medical software. For eg a standalone software\service that helps look for zip code. I am looking for help in creating a quality plan for these types of services... a template or any help would be greatly appreciated. we are ISO13485 certified

Thanks,
 

yodon

Staff member
Super Moderator
#2
Would these services be outside the scope of any medical device?

If not, then you might want to look at IEC 62304. (And if so, be sure your ISO Cert scope supports!)

If so, then it's really at your discretion. A "quality plan" for software has a variety of aspects / connotations. It could be anything from a development plan (with all the "quality checks" along the way) to unit-level quality (static analysis, etc.) to formal test results to post-market failures.

Do your customers have any specific requirements / expectations for such?

If you want to go crazy, look at the set of ISO 25000 standards (ISO 25000 STANDARDS)
 
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