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.
Technologies
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Keywords
medical equipment manufacturinggovernmentfda submissions guidancemedical device regulatory articlesfda compliance educationconsultingsamd regulationmedical device quality supportmedical device innovation supportservicespre-market submission assistanceregulatory strategy planningfda submission supportfda interaction planningfda regulatory supportfda communication strategiesregulatory educationregulatory community engagementmedical device complianceclinical trial supportregulatory compliancemedical device developmentb2bq-submission supportide submission processinvestigational device exemption (ide)510(k) and pma submissionsclinical trial guidancefda guidance reviewfda review process
Company Information
- Employees4
Location
1201 Industrial Ave, North Platte, Nebraska, United States, 69101-7712
