About
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.
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Keywords
medical equipment manufacturing
government
fda submissions guidance
medical device regulatory articles
fda compliance education
consulting
samd regulation
medical device quality support
medical device innovation support
services
pre-market submission assistance
regulatory strategy planning
fda submission support
fda interaction planning
fda regulatory support
fda communication strategies
regulatory education
regulatory community engagement
medical device compliance
clinical trial support
regulatory compliance
medical device development
b2b
q-submission support
ide submission process
investigational device exemption (ide)
510(k) and pma submissions
clinical trial guidance
fda guidance review
fda review process
Company Information
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Employees 4
Location
1201 Industrial Ave, North Platte, Nebraska, United States, 69101-7712
