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MDSAP readiness - Selling clinical product IVDs into Canada
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MDSAP readiness - Selling clinical product IVDs into Canada
MDSAP readiness - Selling clinical product IVDs into Canada
MDSAP readiness - Selling clinical product IVDs into Canada
MDSAP readiness - Selling clinical product IVDs into Canada
MDSAP readiness - Selling clinical product IVDs into Canada
MDSAP readiness - Selling clinical product IVDs into Canada
MDSAP readiness - Selling clinical product IVDs into Canada
MDSAP readiness - Selling clinical product IVDs into Canada
MDSAP readiness - Selling clinical product IVDs into Canada
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  Post Number #1  
Old 13th February 2018, 01:25 AM
TempusVernumProcella's Avatar
TempusVernumProcella

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

I feel like a fish on mars, people

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  Post Number #2  
Old 13th February 2018, 05:19 AM
bio_subbu's Avatar
bio_subbu

 
 
Total Posts: 634
Re: MDSAP readiness - Selling clinical product IVDs into Canada

List of Registrars Recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) - Canada.ca
Thanks to bio_subbu for your informative Post and/or Attachment!
  Post Number #3  
Old 13th February 2018, 01:30 PM
TempusVernumProcella's Avatar
TempusVernumProcella

 
 
Total Posts: 18
Re: MDSAP readiness - Selling clinical product IVDs into Canada

Thank you!

I was under the impression though that BSI did not audit for MDSAP... I feel slightly confused.
  Post Number #4  
Old 14th February 2018, 12:28 PM
mihzago

 
 
Total Posts: 190
Re: MDSAP readiness - Selling clinical product IVDs into Canada

BSI does audit using MDSAP. In fact, I think they were one of the first AOs to get the proper credentials.

FDA's CDRH Learn site has a lot of helpful materials describing the MDSAP program.
CDRH Learn
look under Quality System > Inspections - Global Harmonization

Another key resource is this page: Medical Device Single Audit Program (MDSAP)
Thanks to mihzago for your informative Post and/or Attachment!
  Post Number #5  
Old 14th February 2018, 12:38 PM
bio_subbu's Avatar
bio_subbu

 
 
Total Posts: 634
Re: MDSAP readiness - Selling clinical product IVDs into Canada

Quote:
In Reply to Parent Post by TempusVernumProcella View Post

Thank you!

I was under the impression though that BSI did not audit for MDSAP... I feel slightly confused.
Auditing Organization Availability to Conduct MDSAP Audits
.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf AO for MDSAP Audits.pdf (357.6 KB, 23 views)
  Post Number #6  
Old 21st February 2018, 09:31 AM
DannyK

 
 
Total Posts: 678
Re: MDSAP readiness - Selling clinical product IVDs into Canada

There is a lot of information available about MDSAP audits.
The FDA site provides detailed information.
https://www.fda.gov/downloads/medica.../ucm390382.pdf

MDSAP Audit Procedures and Forms

My company is going through an MDSAP audit this week.
  Post Number #7  
Old 21st February 2018, 09:56 AM
mihzago

 
 
Total Posts: 190
Re: MDSAP readiness - Selling clinical product IVDs into Canada

Good luck, DannyK.
Let us know how it goes.
  Post Number #8  
Old 4th March 2018, 12:34 PM
DannyK

 
 
Total Posts: 678
Re: MDSAP readiness - Selling clinical product IVDs into Canada

Everything went well.
There were no issues raised.
Thanks to DannyK for your informative Post and/or Attachment!
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