Clinical Regulatory Services

Medical Writing

  • Clinical Evaluation Reports (2.7.1/4)
  • Publications, abstracts, white papers

FDA submissions

  • Clinical strategy for product development
  • Clinical study reports

MDR Planning 

  • Gap analysis
  • PMCF Plan & Report
  • PSUR & SSCP

Product Design and Development

  • Clinical strategy
  • Risk assessment
  • Human factors
  • Medical reviews
  • Clinical Procedures

 

Regulatory Affairs Services

Strategic Planning

  • Due diligence research and reporting
  • Product development pipeline
  • Market landscape assessment
  • Target market planning
  • Product classification

Design Controls

  • Design requirements
  • Applicable standards
  • Risk management
  • Verification and validation testing
  • Protocol design and testing
  • Data review and reporting
  • ​Unique Device Identification

FDA Submissions

  • FDA Q-Submissions
  • 510(k) Submissions
  • PMA Submissions
  • 10.75 Appeals for Formal Dispute Resolution

Global Registrations

  • Japan & Asia Pacific
  • Canada
  • European Union (CE Mark Technical Files)
  • Latin America

Medical Device Software

  • Planning & documentation
  • System Integration
  • Risk-Benefit analysis
  • Laboratory Developed Tests
    • Design requirements
    • Validation
    • CLIA Lab Survey Support

Clinical Research Services

 

Strategic Planning

  • Clinical studies
  • Protocol design and development
  • Study budget planning and management

Study Execution

  • IRB/EC approvals
  • Study start-up activities
  • Study Monitoring
  • Data management
  • Clinical study report

 

COLLABORATION

Working with MedReg Consulting, Medicore International will ensure that Clinical Strategies align with regulatory requirements.