US FDA Expert
Patsy Trisler, JD, RAC.
Patsy has been consulting to the medical device industry and academic institutions for more than 25 years. She has been part of the Qserve team since 2012. Patsy began her career in regulatory affairs working at the US Food and Drug Administration in the Center for Devices and Radiological Health. Since then she has held senior management positions with small to mid-size consultancies and clinical CROs. In those capacities, she was the responsible operations’ manager for regional offices as well as head of regulatory/quality. She currently serves as a part-time VP of Regulatory and Clinical Affairs for two start-up companies.
Patsy’s expertise is in medical device and combination products’ regulatory affairs spanning a broad range of product types and therapeutic areas. She provides strategic advice for all stages of new product development and post-marketing activities. She prepares FDA submissions, including Pre-Submissions (Q-Subs), IDEs, 510(k)s, De Novos and RFDs, and serves as the primary contact & liaison between FDA and the client submitter. Patsy has conducted good clinical practice (GCP) workshops and presented at many regulatory affairs and clinical research at national and international conferences on topics related to FDA requirements, submissions, and interactions.
Patsy is regulatory affairs certified (RAC) and is a Washington, D.C.-licensed attorney. She is conveniently located near the FDA’s campus. Prior to her tenure at the FDA, she attained her law degree in a part-time program while working at the National Institutes of Health in a microbiology research laboratory. Her baccalaureate degree is in biology and psychology.
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