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During Darlene Crockett-Billig’s 46+ year career in the medical device industry, she has directed over 300 successful submissions, including PMAs, IDEs, 510(k)s, HDEs, De Novos, and European Technical documentation. Darlene has led regulatory affairs, quality systems, and clinical affairs for a myriad of 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, and she 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. Darlene is a subject matter expert in PMA submissions and ophthalmic and neurostimulation products.