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Estimated time or cost to prepare for MDSAP

  • 1.  Estimated time or cost to prepare for MDSAP

    This message was posted by a user wishing to remain anonymous
    Posted 18-Oct-2017 10:12
    This message was posted by a user wishing to remain anonymous

    If you are a U.S. start-up and already have a QMS complying with 21 CFR Part 820 (QSR), ISO 13485:2003, the EU
    MDD (93/42/EEC) and the Canadian Medical Device Regulations (SOR/98-282),     how much time do you think it takes to get ready for MDSAP?

    For those of you who have transitioned, how much did it cost you (in $ or number of hours)? What was your approach? Did you use the FDA companion document as an internal audit guidance and made your own readiness assessment?

    Did you hire a consultant? If so, how much did it cost you (just as a ballpark)?

    Thanks.


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