Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I work for a small start up and am a bit confused on how complete or advanced the outputs of the product development process need to be for the ISO/MDSAP audit. Assuming design controls will be audited, is it acceptable for objective evidence to be available just for the design stage that is completed at the time the audit occurs or is it a requirement that all design activities need to be completed for the audit? Or is the audit supposed to be timed with the completion of all design transfer activities?

Note that the product will not be approved in the countries of scope by the time the stage 1 and 2 audits occur.

Thanks for your feedback.

Anon,

The audit will focus on your QMS and your adherence to its requirements.  The audit will look at whether you are following your design development process and whatever stage of that process your product is currently in.  The ISO/MDSAP audit has little bearing on the design/development data supporting a marketing approval submission, with the expectation being (with a few exceptions) that all design activities be completed and you have evidence supporting such.

An audit timed with completion of all design activities is not required, and furthermore would likely be detrimental timewise to your market introductions.  This is particularly the case with an initial ISO/MDSAP audit, where there are likely to be nonconformances to be addressed.  With auditing body capacity an issue, best to schedule early.

James

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James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
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Original Message:
Sent: 09-Sep-2019 16:36
From: Anonymous Member
Subject: MDSAP Audit readiness

This message was posted by a user wishing to remain anonymous

I work for a small start up and am a bit confused on how complete or advanced the outputs of the product development process need to be for the ISO/MDSAP audit. Assuming design controls will be audited, is it acceptable for objective evidence to be available just for the design stage that is completed at the time the audit occurs or is it a requirement that all design activities need to be completed for the audit? Or is the audit supposed to be timed with the completion of all design transfer activities?

Note that the product will not be approved in the countries of scope by the time the stage 1 and 2 audits occur.

Thanks for your feedback.

It is best to check with the Auditing Organization (AO) who will be doing the MDSAP audit.  Normally early on (especially during Stage 1, if revealed), there would be some discussion/finding around the state of each process.  If Design Controls had not been implemented fully through Design Transfer, there should be a determination by the AO as to what they would then be willing to certify.  It is possible that they could certify everything other than Design Controls until it is successfully implemented which would then be verified in a subsequent additional audit.  Otherwise, the agreement might be to wait until Design Controls are fully implemented to do the audit and issue the certificate.  I believe that the AO still has the latitude to determine the approach. Cost and audit resource availability might also factor into the approach decided.

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Rem Siekmann BSE, MBA, ASQ CBA
Senior Principal Engineer
Bellaire MI
United States
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Original Message:
Sent: 09-Sep-2019 16:36
From: Anonymous Member
Subject: MDSAP Audit readiness

This message was posted by a user wishing to remain anonymous

I work for a small start up and am a bit confused on how complete or advanced the outputs of the product development process need to be for the ISO/MDSAP audit. Assuming design controls will be audited, is it acceptable for objective evidence to be available just for the design stage that is completed at the time the audit occurs or is it a requirement that all design activities need to be completed for the audit? Or is the audit supposed to be timed with the completion of all design transfer activities?

Note that the product will not be approved in the countries of scope by the time the stage 1 and 2 audits occur.

Thanks for your feedback.