In Reply to Parent Post by Azu2008
(...) Does anyone have a model of rapport of packaging validation/qualification for medical devices?
I take that to be a request for an ISO 11607 validation/compliance report...not just a production-process validation report.
I can't help out because that info is highly proprietary for us. It's taken us over a year of constant work for two engineers, and a ton of money to a testing-services/consulting firm that has two principals heavily involved in 11607 development, and a separate Ph.D. consultant on our end, to get a handle on how to do it right. Our understanding from our consultants is that doing it right is rare at this point...and a lot of that would be learnable from our documentation.
Anyway, that's what I think is being asked for.