Experien Group

Experien Group is a premier regulatory, clinical, and quality consulting firm dedicated to the medical device and diagnostic industries. Founded in 2003 and headquartered in Sunnyvale, California, the company provides strategic guidance to help medtech innovators navigate complex global regulatory pathways. Their expertise encompasses FDA submissions (510(k), PMA, De Novo), clinical trial design and execution, and the implementation of robust quality management systems. Experien Group is particularly noted for its work with high-risk and novel medical technologies. In March 2021, the firm was acquired by Veranex, a global provider of integrated services for the medtech industry, to bolster its regulatory and clinical capabilities.