Experienced Medical Device Consulting
Helping you get your device to the market!
Experienced Medical Device Consulting
Helping you get your device to the market!
Helping you get your device to the market!
Helping you get your device to the market!
I'm Audrey Swearingen, owner and principal consultant. I have been helping medical device companies with their regulatory needs since 1995, first as an employee of device manufacturers, and 8 years as a professional regulatory consultant with a major global consulting company. I find the ever-changing regulatory environment fascinating, and enjoy a challenge!
Understanding and complying with the regulatory requirements is a critical element of your success, and I will put my experience to work to help ensure that success.
My goal is to work with you to understand your product and needs so that I can effectively support you in the regulatory process, from development to post-market.
Whether you're a small start-up without in-house regulatory expertise or a large organization looking for additional temporary support, Swearingen Regulatory Consulting has you covered. I can address simple questions (there's no stupid question when it comes to the FDA!), develop regulatory strategy, and compile your device's 510(k) or de novo submission. My experience includes other activities such as FDA Q-submission meetings, labeling/promotional critique, and post-market support.
See the 'Services' page for more details.
My expertise is assisting medical device companies in understanding and complying with the U.S. FDA regulatory process.
I am experienced in a wide array of medical devices, human tissue products, and combination products. My career includes clearance of over 40 device 510(k)s. A few of the product types I've supported are: dermatology/esthetics, assisted reproduction, infusion needles, exoskeletons, electrodes, surgical systems, bone void fillers, wound dressings, PPE, contact lens solutions, and orthopedic implants. My background also includes evaluating human tissue products for designation as '351' or '361' HCT/P under the PHSA.
I obtained my Regulatory Affairs Certification (RAC) in US regulatory affairs in 1997.
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