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

Elsmar Forum Sponsor
M

MIREGMGR

#3
No feedback from me yet. Our last audit was VARSP. Our first MDSAP audit won't be until this coming Fall.
 

Sarah Stec

Involved In Discussions
#6
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

#7
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

#8
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

#9
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

Staff member
Super Moderator
#10
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 ?
 
Thread starter Similar threads Forum Replies Date
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 15
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 5
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
Edward Reesor MDSAP (Medical Device Single Audit Program) Costs Canada Medical Device Regulations 7
Ronen E FDA encourages industry to participate in Medical Device Single Audit Program (MDSAP) Other US Medical Device Regulations 10
M Has any US Medical Device maker here joined MDSAP yet? Other US Medical Device Regulations 1
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
R Exporting to Canada and MDSAP Canada Medical Device Regulations 7
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
M MDR Impact on MDSAP Countries Other Medical Device Regulations World-Wide 16
Watchcat What's up with MDSAP lately? Medical Device and FDA Regulations and Standards News 2
R What happens during a Stage 1 MDSAP audit? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Comparison essential requirements EU compared to those of MDSAP countries Other Medical Device Regulations World-Wide 3
J MDSAP Companion and HC requirements Canada Medical Device Regulations 4
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
B MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record Other Medical Device Regulations World-Wide 3
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
W Informational MDSAP Substantial change / Change of notice forms Document Control Systems, Procedures, Forms and Templates 2
XRAY_3121 Informational MDSAP Audit Findings - Document change orders Other Medical Device Regulations World-Wide 12
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
M Medical Device News EU interesting developments – embracing MDSAP and UDI alignment Medical Device and FDA Regulations and Standards News 0
M Medical Device News MDSAP Stakeholder Day – December 5, 2018 presentations Medical Device and FDA Regulations and Standards News 0
Ajit Basrur MDSAP Presentations - Dec 5, 2018 - Stakeholders Other Medical Device Regulations World-Wide 0
JoshuaFroud FDA Form MDSAP AU F0029.1.004 - Help with Completion US Food and Drug Administration (FDA) 0
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Sidney Vianna Interesting Discussion Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate? Canada Medical Device Regulations 0
T MDSAP AO Cost ISO 13485:2016 - Medical Device Quality Management Systems 2
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
S Initial Importer and ISO 13485 (MDSAP) - Will the US company be included? ISO 13485:2016 - Medical Device Quality Management Systems 1
S MDSAP Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
K MDSAP scope vs ISO 13485 Scope Canada Medical Device Regulations 4
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
D How will the new MDSAP requirements affect the MDEL? Canada Medical Device Regulations 1
B Our NB doesn't accept new clients for MDSAP Canada Medical Device Regulations 8
A MDSAP benefit for manufacturer of low-risk devices Canada Medical Device Regulations 3
R Impact of an MDSAP certificate with all countries coverage Other Medical Device Regulations World-Wide 8
A ISO-13485 7.1 - Preparing for our MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is a reasonable MDSAP cost? ISO 13485:2016 - Medical Device Quality Management Systems 9
Edward Reesor Canadian News article on impact of MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 10
C Substantial Change in MDSAP Audit Other Medical Device Regulations World-Wide 1
S How can we demonstrate to MDSAP auditors that we have the requisite training ISO 13485:2016 - Medical Device Quality Management Systems 9
T MDSAP readiness - Selling clinical product IVDs into Canada Canada Medical Device Regulations 7
F MDSAP vs "Full" FDA Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Question about Australia - TGA and MDSAP - Technical file ISO 13485:2016 - Medical Device Quality Management Systems 3
S TGA regulations and ISO 13485:2016 gap analysis MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom