Darlene Garner has more than 30 years of regulatory experience in the medical device industry. Her regulatory career has included experience with various medical devices (Class I, II and III), such as pacemakers, vagus nerve stimulators, intravascular radiotherapy systems, peripheral stents, TENS units, guide wires, and catheters. She has successfully submitted multiple applications for product approvals and has been involved in several FDA and Notified Body inspections.
Darlene has worked at large companies and startups, advising on product classifications, regulatory strategies, submissions, technical files, medical device reporting, and agency inspections. Her submission experience includes 513(g), 510(k), pre-IDE, IDE, PMA, EU technical files, Canadian applications and various country registrations.
She has specialized in regulatory affairs for several organizations including Sulzer Intermedics, Guidant, and IDEV Technologies. Darlene holds a degree in biology from the University of Houston.