Since joining MCRA in 2021, Mr. Sutton has developed and reviewed US regulatory submissions for medical devices including 510(k)s, De Novos, PMAs, IDEs, and various Pre-Submissions including Breakthrough Device Designation requests. He also specializes in the development of international regulatory submissions including regulation-compliant Clinical Evaluation Reports, and comprehensive PRISMA guided literature evaluations. Mr. Sutton has experience in development and implementation of regulatory strategy and regulatory submissions in therapeutic areas including orthopedic and spine with additional experience in cryoablation therapies.
Mr. Sutton hold a Bachelor of Sciences in Bioengineering with a concentration in Biomaterial from Clemson University.
Overview
Mr. Sutton supports US and international regulatory strategy and submissions for the MCRA Regulatory Affairs department. Mr. Sutton specializes in writing and reviewing regulatory submissions, developing overall regulatory strategy, and communicating with regulatory bodies and clients. MCRA’s Regulatory Affairs department has the staffing expertise in the neuro-musculoskeletal disciplines, and carefully cultivated relationships and experience with U.S. government agencies enabling clients to operate, expand, and achieve their long-term business objectives.