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Old 13th February 2018, 01:25 AM
TempusVernumProcella's Avatar

Total Posts: 18
Please Help! MDSAP readiness - Selling clinical product IVDs into Canada

Hello and help!

My employer is very eager to sell clinical product IVDs into Canada; I am well aware of needing a particular audit outside of our BSI (ISO 13485:2016) spectrum.
Anyone have experience with this?
Standards and thrilling page-turners?

I feel like a fish on mars, people

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