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MDSAP readiness - Selling clinical product IVDs into Canada

  • Thread starter TempusVernumProcella
  • Start date
T

TempusVernumProcella

#1
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?
Registrars?
Links?
Standards and thrilling page-turners?

I feel like a fish on mars, people :confused:
 
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T

TempusVernumProcella

#3
Thank you!

I was under the impression though that BSI did not audit for MDSAP... I feel slightly confused.
 
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