Ronald K. Eisenwinter, has over 30 years of experience with FDA regulated companies that manufacture medical devices, in vitro diagnostics, biologics, and pharmaceuticals. While at PB Diagnostics, he worked in areas of biochemistry and systems engineering, eventually managing Clinical Affairs and Technical Support. Over the past 20 years as a consultant, he has done regulatory submissions (Pre-Submission, 510(k), de novo, PMA, IND, BLA, CLIA Waiver), FDA mock audits, software validations and 21 CFR Part 11 compliance, clinical evaluations, GCP audits, crisis management for Warning Letters and Consent Decrees, and SOP and Quality System development. Ronald Eisenwinter is an educated biologist and computer scientist who worked in development of IVC instruments before becoming a requaltory and quality consultant in 1995.