Darlene Crockett-Billig , MBA

President
Medical Device Consulting Firm
Sunnyvale, California

Darlene started her medical device industry career 33 years ago at Medtronic. She went on to work for Miles Laboratories, CooperVision Ophthalmic Products, and KeraVision, holding senior management positions since 1987. At KeraVision, Darlene was responsible for the regulatory, clinical and quality activities associated with the company?s successful effort to obtain FDA approval of a new Class III Panel Track ophthalmic implant and its associated surgical instruments. During her career, Darlene has directed over 300 successful submissions including PMAs, IDEs, 510(k)s, HDEs, Technical Files and Design Dossiers. She has also provided regulatory and quality leadership for a variety of implantable cardiovascular pacemakers and leads, parental and nutritional IV solutions and administration sets, ophthalmic drugs, contact lenses and contact lens solutions. Darlene is an expert in validation testing including sterilization (ethylene oxide, radiation, steam and dry heat) and aseptic processing. She has developed a fully-customizable, comprehensive Quality Management System for Experien Group clients and is a standout in the field for assessing and securing compliance with FDA?s Quality System Regulation, ISO 13485:2003, ISO 14971:2007, the European Medical Device Directive and Health Canada?s Medical Devices Regulations. Darlene received her B.A. degree in Biology from Augustana