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

somashekar

Leader
Admin
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 ...
 

Attachments

  • Jan 2015 Announcement - MDM Participation to MDSAP.pdf
    93.3 KB · Views: 300
Last edited:

Stijloor

Leader
Super Moderator
A Quick Bump!

Please help a fellow Cover with providing feedback!

Thank you very much!!
 
M

MIREGMGR

No feedback from me yet. Our last audit was VARSP. Our first MDSAP audit won't be until this coming Fall.
 
S

Sarah Stec

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." :) :2cents:
 
M

MIREGMGR

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.
 
M

MIREGMGR

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...?
 
1

17Angels

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 ...

Some insight to the process:
The AO qualifications (witnessed audit segment) requires 3 audits and it takes quite a bit of time to plan and execute (dealing with 4 regulatory bodies).
Bear in mind that the auditor team members must also be qualified to MDSAP prior to undertaking the witnessed audit. There are 10 basic training modules and additional training modules from each regulatory body.
All factors combined make for a lengthy process for AO qualifying. :agree:


:D
 

somashekar

Leader
Admin
Some insight to the process:
The AO qualifications (witnessed audit segment) requires 3 audits and it takes quite a bit of time to plan and execute (dealing with 4 regulatory bodies).
Bear in mind that the auditor team members must also be qualified to MDSAP prior to undertaking the witnessed audit. There are 10 basic training modules and additional training modules from each regulatory body.
All factors combined make for a lengthy process for AO qualifying. :agree:


:D
Add to it, that the Industry has to voluntarily opt for the MDSAP and as such the AO's now are far less compared to the ISO13485 CB's in market.
This will mean changing the CB, which for many is not a welcome move.
The other options of GMP inspection are still open and FDA inspection again is for free and at the FDA discretion.
There is nothing to motivate the industry to go to the MDSAP.
Can anyone tell what it costs the company for the MDSAP as against the ISO13485 ?
 
Top Bottom