Mike Righter

Mike brings experience in Regulatory Affairs and a history of working in the medical device and pharmaceutical industry to his role as a Regulatory Advisor for HitCheck. Skilled in Research and Development (R&D), U.S. Food and Drug Administration (FDA), CE marking, Risk Management, Medical Devices, and GxP Quality Management Systems. Mike has been an end-to-end manager of regulatory submissions, strategy and execution. His current focus is in digital health diagnostics and therapeutics, software as a medical device (SaMD) and mobile medical apps.