Confidence Beyond Compliance

Strategy (Plan)

  • QMS gap assessment
  • Compliance strategy
  • Site quality plan
  • Communication plan

Synergy (People)

  • Organizational design
  • Quality culture activities
  • Inspection / Audit readiness (QSRs / QSIT, ISO13485 / MDSAP)

Optimize (Performance)

  • Process and product quality metrics
  • Compliance maintenance (including training, annual auditing, regulatory reporting / filing)
  • Post-market surveillance reports
  • CAPA effectiveness
  • Actions from regulatory intelligence monitoring

Operation (Process & Product)

  • Documented quality management system (QMS)
  • Technical documentation (DHF / CERs)
  • QMS implementation (including training, validation of tools-CSV)
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