Sharepoint for ISO 13485 QMS for small IVD company

#11
I have experience transitioning and establishing ISO 9001:2015 using SharePoint site. It is a bad idea having external consultant do this job for your company. After the consultant is done, there will be very little ownership from your stakeholders internally.
It is not that difficult to work internally.
Actually I have experience on setting up the SharePoint pages so that is not an issue. What I am wondering is if BPA Solutions would meet Medical Device requirements as it is different from ISO 9001.
You need to consider so many standards and regulations to comply with. From FDA (21 CFR-Part 11, Part 820), Health Canada Requirements, ISO 13485, ISO 14971 and IEC 62304.
 
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Ed Panek

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#12
We used SharePoint for University Research QMS. It had revision controls and we set up process flows but we could not use it for signatures.
 
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