Hello Michelle,
Well I wish that there some nice words that I could say for your client and that Intertek was an exception, but seems to be par for course currently. Maybe it will be better ...
If you are not receiving a response from Intertek, would suggest to file a "complaint" with the MDSAP program manager at Intertek. Or elevate it further up to the AO accreditation contact (listed on the FDA's website for MDSAP). It is important to get the information to Health Canada for transition package otherwise the medical license may be in jeopardy for non-renewal of QMS certification. Wish I had more positive words to say.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Jan-2019 13:27
From: Michelle Lott
Subject: Intertek's support for MDSAP transition packages
Hello
I have a client who was due for an Intertek MDSAP and ISO transition audit at the end of the year last year (with their certificates expiry in December as well). Intertek canceled their audit scheduled at end of December without confirming a new date. They told my client not to worry that they have done several successful HealthCanada transition packages to extend the audit dates. However, so far this year they have been unresponsive to schedule an audit date or tell the client what he needs to provide for the transition package. We are concerned that the package won't be filed on time to meet the Canadian deadlines. Does anyone have experience with Intertek in this regard or with HealthCanada transition packages to extend the deadline in general?
Thanks for the insight.
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Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
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