Quality Systems

  • SterlingTech Software can assist with any area of your Quality System development or execution. We can do the work under our ISO13485 certified Quality system or under your Quality System.

    • Quality System
      • Review existing Quality System to identify areas of concern
      • Develop remediation plan
      • Execute remediation plan
    • Risk Assessment & Hazard Analysis Consulting
    • Design History File Remediation
      • Review existing artifacts to identify area of concern
      • Develop remediation plan
      • Execute remediation plan
    • GMP/QSR/ISO Review
    • Process Validation - IQ/OQ/PQ
    • Electronic Record keeping
    • Part 11 Compliance Review
    • Software Quality Assurance
    • Training of your employees in FDA or ISO approved Medical Device Software Development Methodologies and Processes
    • IEC 60601-1 Medical Device Safety Consulting
    • Documentation Services