Anon #2 has already said pretty much all that needs to be said, so I'll just second that approach. And I'll add that all of the mid and larger sized medical device companies with whom I've worked always had the Sales and Marketing team owning/driving the design and development sub-process for advertising and and promotional literature (i.e., for labeling), yet with Regulatory as a mandatory stakeholder. So your vision certainly has strong precedent.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 02-Apr-2023 21:33
From: Anonymous Member
Subject: Adv & Promo Review Process
This message was posted by a user wishing to remain anonymous
Regulatory does not have to be the owner, and in my opinion, should not, but should definitely be one of the document approvers of all the public facing documentation (labels, promotional materials, etc). RA should put effort and emphasis on educating the Marketing/Commercial teams on the implications of any off-label advertising, device use (field study, as they sometimes call it). All the documentation used in advertising/promotional should be diligently updated for ant technical specifications and their changes throughout the lifecycle, hence, there could be a link in your QMS to trigger such update during design reviews, etc.
Original Message:
Sent: 30-Mar-2023 23:33
From: Anonymous Member
Subject: Adv & Promo Review Process
This message was posted by a user wishing to remain anonymous
I'm Regulatory Affairs manager for a small-ish (but growing) device manufacturer. As one of the few original people in the company with experience in the device industry (and being in Regulatory), I was tasked with ownership/oversight of the Adv & Promo review process and tools, in addition to conducting the Regulatory review and approval of materials.
Now that the company is more mature and has more experienced staff I would very much like to become a key stakeholder in the A&P process instead of the owner. Curious how other companies have carved this out? Does Marketing own the process and tools? If so, how do you make sure they're not taking shortcuts or ignoring regulations?