Services

Medical Device Consulting Firm

Regulatory Consulting Company

Regulatory Affairs Consulting Services

  • Regulatory Strategy
  • Product Classification
  • Pre-sub (Q-Sub)
  • Device Registration and Listing
  • Submissions
  • 510(k)
  • PMA
  • IDE
  • Medical device research studies
  • EU MDR Guidance and Documentation
  • Clinical Evaluation Reports (CER)
  • CE Mark approval processing
  • Post-Market Clinical Follow-up (PMCF) studies and reports
  • Post-Market Surveillance (PMS)
  • Gap analysis
  • Clinical Research Study
Regulatory Consultants

Project Management Consulting Services

  • Product development phase support
  • Definition of project scope, budget, and objectives
  • Design input guidance
  • Planning and risk analysis
  • Streamline point of contact
  • Project maintenance and support
Regulatory Contractors

Clinical Research Consulting Services

  • Support in the development and writing of Study Protocols, Consents, Literature analysis, and Clinical Evaluation Reports.
Medical Device Consulting Firm

Talent Recruitment Consulting Services

  • Support with talent screening, job writing and posting, interview set-up and coordination.
  • Our talent recruitment team are experienced professionals within Medical devices with intimate understanding of Regulatory Affairs, Clinical Research and Project Management.
  • Our customized approach allows us to recruit the right talent for your organization.

Serving clients remotely all over the United States.

Contact Trinity M Consulting LLC. Today!