Sade Sobande is an RAC-Devices accredited regulatory affairs professional with over 13 years of experience in the medical device industry. Sobande has a BEng in chemical engineering from the University of Manchester, U.K., and an MSc in biochemical engineering from University College London, U.K. She is passionate about regulatory strategy and submissions and supporting customers in getting prepared to achieve regulatory compliance to get their products to market. She specializes in regulatory strategy and submissions for medical device software.
Her expertise includes international regulatory compliance for class I-III CE marked devices; class II-IV MDLs for Health Canada; compilation of FDA 510(k)s; and regulatory submissions/registrations in MENA and APAC territories.