FDA, Good Manufacturing Practices GMP, quality system QSR, ISO 13485 regulatory consultants manufacturing development device, drug, diagnostic, combination medical products, 510(k), PMA, IDE

Post-Market Support -
Responding to Real World Experience

Leverage the industry experience and knowledge base of The Tamarack Group to develop systems that support compliance in post-market activities and effectively utilize post-market feedback. We guide the development of –

  • Product distribution controls
  • Customer feedback systems
  • Product stability testing programs
  • Post-market surveillance studies
  • Biological product deviation reporting systems
  • Complaint handling systems
  • MDR / Vigilance / Adverse Event Reporting systems
  • Removal and recall plans
  • Warning and untitled letter responses

See our book on Risk Management !!