Darlene co-founded Experien Group (now Veranex) with Michael J. Billig. During her 40+ year career in the medical device industry, Darlene has directed over 300 successful submissions, including PMAs, IDEs, 510(k)s, HDEs, de novos, technical files, and design dossiers. She has been responsible for regulatory affairs, quality systems, and clinical research activities for a myriad products, including implantable and active implantable devices, combination products, in vitro diagnostics, and instruments. Darlene is an expert in validation testing, including sterilization (ethylene oxide, radiation, steam, and dry heat) and aseptic processing.
Darlene is an expert in interpreting U.S. and international standards and regulations for clients. She additionally provides virtual executive leadership and strategic project support for client companies advancing U.S. Class I, Class II, and Class III medical devices and combination products. For several clients, Darlene functions as the acting vice president of regulatory, quality, and clinical, representing the companies in interface with regulatory agencies, investors, and more. She has developed a fully customizable, comprehensive quality management system for Veranex clients. Her work primarily involves:
- Interfacing with U.S. and international regulatory agencies for product submissions and facility audits/inspections
- Quality management system development
- Quality management system compliance support (e.g., FDA’s Quality System Regulation 21 CFR Part 820, ISO 13485, EN ISO 14971, ISO 10993, the European Medical Device Directive (MDD), and Canada’s Medical Devices Regulations)
- Product testing considerations and preclinical research
- Manufacturing, suppliers, and distribution (e.g., validations, technology transfers, and supplier quality)
- FDA and international compliance activities (e.g., MDRs, vigilance reporting, and field actions)
- Clinical trial design and clinical trial management
Past companies and experience
Darlene started her medical device industry career in 1975 at Medtronic. She went on to work for Miles Laboratories, CooperVision Ophthalmic Products, and KeraVision, holding senior management positions for medical device companies since 1987. She provided regulatory, clinical, and quality leadership for a variety of products, including implantable cardiovascular pacemakers and leads, parental and nutritional IV solutions and administration sets, ophthalmic drugs, contact lenses, and contact lens solutions. As KeraVision’s Vice President of Regulatory Affairs, Clinical Research, and Quality Systems, Darlene successfully led the company’s efforts to obtain PMA approval for a new Class III ophthalmic implant and its associated surgical instruments, securing unanimous FDA panel approval for the PMA product. She has been responsible for over 50 medical device clinical trials.
Darlene received her B.A. in biology from Augustana College in Sioux Falls, South Dakota, and earned her MBA from the College of St. Thomas in Minneapolis, Minnesota.