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Quality Management System for a Healthcare Device Distributor

Digitizing Quality Processes to Ensure Compliance and Traceability

  • Client
    A-Madar Medical
  • Completion
    2025
  • Project type
    AWS, Cloud, QMS

Implemented a tailored Quality Management System (QMS) for a healthcare device distributor to streamline compliance, documentation, and audit readiness. The solution included modules for document control, non-conformance reporting (NCR), CAPA, supplier management, and internal audits. Designed to support ISO 13485 and FDA distribution guidelines, the platform improved visibility across the supply chain, reduced manual errors, and ensured full regulatory alignment.