ISO 13485 - Medical Device Quality Management System Standard

DuncanGibbons

DuncanGibbons

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Gwhittaker22 said:
Hello Marc:

Would you know if there are any GAP analysis between ISO 13485 & AS9100? I work for a DOD subcontractor but I need to understand how the FDA, CFR 21 overlap with AS9100. I will be dealing with contracts based in the FAR and FDA simultaneously...

George
Click to expand...

I presented a conference paper whereby a gap matrix between the two standards was developed, this could be of interest to you.

https://www.researchgate.net/public...S_9100D_FOR_AN_ADDITIVE_MANUFACTURING_COMPANY
 
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