Combination Product Expert Carolyn Dorgan Has Joined Suttons Creek As Principal Systems Engineer
The Californer/10172746

WESTLAKE VILLAGE, Calif. - Californer -- Carolyn Dorgan is bringing her 10+ years of experience in the Medical Device and Combination Product industries, including 6 years leading the FDA's Infusion Devices team, to Suttons Creek. Known in the international regulatory community from her active speaking engagement schedule, Carolyn has literally "set the standard" by participating in over a dozen international standards ranging from infusion devices to needle-based injection systems, on-body delivery systems, and infant incubators. Her knowledge of international Combination Product standards and, more critically, their interpretation and application to various drug delivery devices will play a crucial role in SCI's regulatory services team, led by Rob Schulz, VP of Regulatory Affairs & Technical Consulting.

"Carolyn is well known for her active engagement with both medical device and pharmaceutical companies during her tenure at the FDA and was in the regulatory approval of products for which there are no established performance or regulatory standards – such as pediatric medical devices, novel on body drug delivery systems, and rare disease combination products," says Schulz. "We are excited to have her on board to forge new pathways to success for our clients' innovative and groundbreaking projects."

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Carolyn has a B.S. in Biomedical Engineering from the University of Minnesota and M.S. in Technology Commercialization from the University of Texas. These academic diplomas, in conjunction with her multi-disciplinary career experience in engineering, software, cybersecurity, human factors, and business will make Carolyn a critical contributor on many Suttons Creek client projects to come.
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Suttons Creek is a full-service medical device consultancy that partners with pharmaceutical companies, providing services (https://suttonscreek.com/combination-product-services-regulatory-guidance-development-training) including expert consulting, embedded execution, training and guidance for the development of combination products. Its services create success in global regulatory affairs, quality systems, device engineering, commercial launch and digital support platforms throughout the entire product lifecycle. Suttons Creek consultants have a combined 650+ years of medical device and combination product experience, working on over 60 products, encompassing a wide variety of drug delivery systems and supporting digital software, for over 50 pharma clients. Their team of medical device experts provides support clients through the entire product life cycle, from project inception to commercialization and post-launch activities.

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To learn more about Suttons Creek, visit www.suttonscreek.com or call 877.611.4724 to speak to a member of the Suttons Creek team.

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