Senior Advisor - Shelley Buchen, MS, University of Wisconsin
Ms. Buchen will work with Mass Spec Lab in biocompatibility assessment and safety risk analysis for devices, biotech, and pharma applications fields.
Ms. Buchen worked for AMO from 1982 through 2005 in research and development of ophthalmic implants with biocompatibility testing strategy development and oversight of testing being her primary areas of focus. She was a member of the U.S. delegation to ISO/TC 172/SC7 in standards development for intraocular lenses, ophthalmic viscosurgical devices, endotamponades and irrigating solutions and she served as project leader of ISO11979-5 on biocompatibility.
Ms. Buchen subsequently worked for the U.S. FDA/CDRH/ODE/DOED from 2007 to 2013 as a scientific reviewer of regulatory submissions with primary responsibility in biocompatibility review of ophthalmic implants, contact lenses, lens care solutions, and single-use ophthalmic devices. She also performed biocompatibility review of devices used in dural repair, cranioplasty, and cardiovascular surgery. She was co-investigator in TASS (Toxic Anterior Segment Syndrome) research while at the FDA.