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Karen Frostad

Karen Frostad utilizes her regulatory experience and analytical skills to help clients develop cogent briefing materials, including FDA Panel Packs. Prior to joining 3D Communications, Karen led Pre-Submission, IDE, and PMA activities for Allergan Medical and Agilent Technologies. She also managed EU/international filings for Abbott Vascular. Karen identified approval pathways to optimize product lifecycle management from early development through post-market use. Karen has worked with medical devices, companion diagnostics, and drug-device combination products in therapeutic areas such as dermatology, bariatric surgery, diabetes, pediatrics, cardiovascular disease, and oncology.