Darlene is a proven executive in the medical device industry, having co-founded Experien Group in 2003 and supported numerous companies in bringing innovative products from inception to commercialization. During her 45+ 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, and quality systems activities for a myriad of medical devices, including active implantable devices.

Darlene started her medical device industry career at Medtronic. She provided regulatory, clinical, and quality leadership for a variety of products, including implantable cardiovascular pacemakers and leads.

Darlene received her BA in Biology from Augustana College and MBA from the College of St. Thomas