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 (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)

 

Regulatory Consultants

Project Management Consulting Services

  • Product Development 
  • Lean Six-Sigma 
  • 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 with Medical Writing (Study Protocols, Brochures, Consents, etc.)
  • Literature Analysis
  • Clinical Evaluation Reports
  • Support with EU MDR Clinical Requirements 
Medical Device Consulting Firm

Talent Recruitment Consulting Services

  • Support with Talent Screening
  • Job Writing and Posting
  • Candidate Interview Set-up and Coordination
  • Consultancy Placement