Speaker Profile

Joy Frestedt

President and CEO, Frestedt Incorporated

Joy Frestedt, PhD, CCTI, RAC, FRAPS. Dr. Frestedt is the President and CEO of Frestedt Incorporated, a novel virtual Contract Research Organization network of over 50 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries especially running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally. She has held key positions including vice president of scientific, regulatory and clinical affairs at BridgePoint Medical and Humanetics Corporation as well as key management positions with Johnson and Johnson’s Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZenca Pharmaceuticals and Orphan Medical. Dr. Frestedt holds a B.A. in biology from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School and she is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, American Society of Clinical Research Professionals and she is a Fellow of the Regulatory Affairs Professionals Society. Dr. Frestedt was named one of the “100 Most Inspiring People in the Life Sciences Industry (by PharmaVOICE, 2011) and one of the top 25 “Industry Leaders/ Women in Business Award (by the Minneapolis/St. Paul Business Journal, 2011).

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EU Medical Device Classification

It is not economically feasible to subject all medical devices to rigorous conformity assessment procedures. A more appropriate graduate system is now available that manufacturers should be able to determine the classification of their product early in the development stage. This medical device classification webinar will review the risk based approach of the EU classification system. This webinar will review two documents on this topic including the "Medical Devices: Guidance Document - Classification of Medical Devices" and "EU Council Directive 93/42/EC (as amended) - Annex IX Classification Criteria" which is applicable on the classification rules for medical devices which intend to ensure a high level of human health and safety.

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