Mr Regulatory

Mr Regulatory is a California based corporation specializing in medical device regulatory education and consulting services. • Providing training resources and regulatory and quality support for PMAs, 510(k)s, IDEs, and pre-submissions to FDA. • Ex-FDA advice on regulatory strategy, as well as hands-on guidance for navigating challenging FDA interactions. • Successful 510(k)s, Q-subs, IDE submissions, and preparation for FDA inspections and audits for various clients. Primarily assisting small and medium sized medical device startups.