Services

Quality

  • Quality Management System (Establishment, Maintenance, Remediation) 
  • Training Implementation 
  • Internal / External Audit Support
  • CAPA Management
  • Field Actions (Corrections, Removals)
  • Post-Market Surveillance 
  • Risk Management 

Regulatory

  • Regulatory Strategy
  • FDA Warning Letter / 483 Responses
  • Global Registration Support
  • Technical File / Design History File Maintenance and Review
  • Labeling, Promotion, and Advertisement Reviews 
  • Device Classification 
  • UDI Maintenance 


Clinical

  • Clinical Evaluation Support (CEP, CER)
  • Management of Clinical Complaints or Adverse Events
  • Clinical Input or Review for Product Design and Development 
  • Health Hazard Evaluations
  • Clinical Advisory