|
Patsy Trisler, Regulatory Consultant and Member of the Board of Directors, has over 18 years experience in FDA regulatory affairs. She has been a consultant to the medical device industry since 1991, serving as the external RA resource to many start-up companies. Her expertise is in strategic planning related to regulated-product pathway, FDA submissions and requirements for pre-clinical and clinical testing, as well as post-approval requirements, including compliance with GMP’s under the Quality System Regulations. From 1998 to 2003, Ms. Trisler was employed by multi-national clinical contract research organizations (CRO), where, in addition to direct consulting with medical device clients, she provided regulatory support to assure compliance with Good Clinical Practices. Ms. Trisler provided regulatory assistance to Exogen, Inc., prior to its acquisition by Smith & Nephew, Inc., and since has been the external consultant to Smith & Nephew on regulatory matters related to the Exogen product line. During that time she assisted Mr. Ryaby on FDA matters pertaining to the MST technology. From 1985 to 1991 Ms. Trisler was on the staff at the FDA’s Center for Devices and Radiological Health. During that time she was the lead scientific reviewer for electrical, electromagnetic and ultrasound bone growth stimulator devices. Prior to working at the FDA, Ms. Trisler was a laboratory technician at the NIH’s National Cancer Institute. Her undergraduate degree is in Biology from the American University, and she earned the J.D. degree from Potomac Law School. She is a licensed member of the District of Columbia Bar and is also a certified regulatory affairs professional (RAC). | 