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MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

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  Post Number #1  
Old 12th March 2015, 11:47 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,371
Thank You! MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

Medical Device Single Audit Program...
Have any of you contracted with any AO for the MDSAP audit ?
Have any of you gone through the stage 1 / stage 2 of the MDSAP audit ?
Please share your feedback here ...
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File Type: pdf Jan 2015 Announcement - MDM Participation to MDSAP.pdf (93.3 KB, 137 views)

Last edited by somashekar; 12th March 2015 at 11:57 AM.

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  Post Number #2  
Old 18th March 2015, 05:06 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

A Quick Bump!

Please help a fellow Cover with providing feedback!

Thank you very much!!
  Post Number #3  
Old 18th March 2015, 06:07 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

No feedback from me yet. Our last audit was VARSP. Our first MDSAP audit won't be until this coming Fall.
  Post Number #4  
Old 11th May 2015, 05:48 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,371
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

THIS does not look very healthy for the MDSAP...
6 out of the 13 AO's available and none so far have Successfully Completed the Pilot assessment Criteria to include Witnessed Audits. ...
Thank You to somashekar for your informative Post and/or Attachment!
  Post Number #5  
Old 11th May 2015, 09:17 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,219
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

Thanks for the update, somashekhar
  Post Number #6  
Old 11th May 2015, 12:04 PM
Sarah Stec

 
 
Total Posts: 89
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

At least a couple of the AOs that have a "No" in the last column are in the middle of performing their requisite witnessed audits (as they are also available to perform MDSAP audits, per the second column). So, personally, I see it more as "the process isn't finished yet" instead of "something is wrong."
  Post Number #7  
Old 11th May 2015, 05:35 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

I haven't talked with Angie Combs of BSI in a while, but several months back they were doing their first observed MDSAP audit...I don't know where. The provided table would seem to indicate that something about that observed audit was not successful...either the process or the candidate...and that they haven't done any other ones since then that were successfully completed.
  Post Number #8  
Old 11th May 2015, 05:38 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

Quote:
In Reply to Parent Post by Sarah Stec View Post

At least a couple of the AOs that have a "No" in the last column are in the middle of performing their requisite witnessed audits (as they are also available to perform MDSAP audits, per the second column).
It's not that I doubt this information, but I'm drawing a blank on how we know this from what's in the table...?
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