Regulatory Affairs Consulting Services

Medical Device Consulting Firm based in Florida

Regulatory Affairs Consulting Services
  • Regulatory Strategy
  • Product Classification
  • Pre-sub (Q-Sub)
  • Device Registration and Listing
  • Submissions (510k, PMA, IDE, NDA)
  • EU MDR Guidance and Documentation
  • EU MDR Submission
  • Clinical Evaluation Reports (CER)
  • CE Mark Approval Processing
  • Post-Market Clinical Follow-up (PMCF) 
  • Post-Market Surveillance (PMS)
  • Gap Analysis
  • Authorized Representative (EU /UK)

Services offered by Trinity M Consulting, LLC.: Regulatory Affairs Consulting Services | Project Management Consulting Services | Clinical Research Consulting Services | Quality Systems Consulting Services | Talent Recruitment Consulting Services

If you are looking for a medical device regulation consultant, we would love to talk with you. We offer a free consultation to discuss how we can help your company succeed.
We look forward to hearing from you soon!

Contact Trinity M Consulting, LLC. for Regulatory Affairs Consulting Services