Quality System and Compliance Solutions

  • Quality manuals and quality systems implementation
  • Quality Suite Development –   GXP, GLP, GMP, QSR, ISO 13485, ICH
  • Liaison to the FDA (Meeting preparation, submissions and FDA response)
  • Liaison to International Notified Bodies
  • Compliance training programs (ISO, GXP, GCP, MDR, IVDR)
  • Internal and Supplier audits (Compliance, CE Mark, CAPA verifications, MDSAP)
  • Supply Chain Management
  • MDSAP and Remote Auditing systems for compliance
  • CE Mark compliance development
  • Corrective Action/Preventive Action (CAPA)
  • Dodd-Frank: Conflict Free Metals

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