Cart 0

Medical Device Industry

 

 

 

 

Strategy

Customized Analyses and Recommendations to Meet Your Regulatory and Communications Needs

We provide Regulatory Planning that ensures optimization of

  • regulatory submissions
  • promotional communications
  • brand strategies

that fit your Company's specific needs for long-term regulatory compliance


Management

We offer management of Regulatory Affairs departments with a focus on:

  • strategy
  • submissions
  • employee oversight
  • regulatory compliance

Deliverables

  • Experience with 510(k), PMA, IDE, and INDs
  • UDI System Strategy & Management
  • Post-Market Surveillance
  • Coordination of International Recalls
  • Establishment and maintenance of CE Marks (Tech File and Clinical Evaluation Reports)
  • Labeling
  • Provider Training Materials
  • Ad Copy Review

Additional Services

  • Risk management
  • Inspection and Certification Preparation
  • Regulatory planning
  • International Recall Coordination
  • Remediation Planning and Execution
  • Corporate and Stakeholder communications