History
O'Connell & Myers was established in 2014 with the goal of helping start-ups and small medical device companies navigate the FDA's regulatory process to get their first FDA clearance or approval, to set up their Quality Management Systems, or to assist manufacturers who lack expertise in the design control aspect of regulatory affairs.
In addition we specialize in helping international manufacturers and distributors obtain the FDA approvals necessary to introduce their medical devices into the United States market.
O'Connell & Myers follows current regulations and guidances to provide accurate and fair regulatory advice to all customers. When you choose to work with O'Connell & Myers, we know that the devices that enter the marketplace will carry your reputation as well as ours. This is a matter that we take extremely seriously because we are only successful when you are successful.
Get in touch
We at O'Connell & Myers know that partnering with the right regulatory consulting firm can save you time, money and market opportunity.
We offer a free 30-minute consultation to understand your device, timeline and budget. Book a time below, send a short note through the contact form, or email info@oconnellandmyers.com.
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Meet Trey
Trey Thorsen, MS, RAC · President
Trey has 20 years of regulatory experience in medical devices. He has written or supported 13 FDA 510(k) clearances across eight review panels, including orthopedic implants, cardiovascular, neurology, radiology software, ENT, general hospital, surgical lighting and women's health, along with PMA work on Class III active implantables.
Before leading O'Connell & Myers, he prepared Class III PMA submissions for implantable pulse generators at St. Jude Medical, cleared a new surgical light at Stryker, built a QSR-compliant quality system as Director of Regulatory Affairs and Quality at HARTMANN USA, and wrote his first 510(k)s at Femasys, where he also coordinated an IDE clinical study.
He holds an M.S. in Regulatory Affairs from the University of Georgia and a B.S. in Chemistry from Millsaps College, and has been Regulatory Affairs Certified (RAC) since 2009.
His approach is simple: explain the device so clearly that the reviewer has nothing left to ask. "They can always poke holes in rationale. They can't poke holes in data."