• Establishing, Implementing and Maintaining Quality Systems and Products to be compliant with:
    • US / EU / CA / JP / IL Medical Device Regulations

    • US / EU Pharmaceutical Regulations

    • US / EU GLP Regulations

    • Quality Management System Standards

    • Risk Management Standards
    • Software Development Standards
    • Safety Standards
    • Usability Standards
    • FDA / ICH / GAMP / PIC/S / GHTF guidelines

  • Preparing and Escorting External Audits
  • Developing:
    • Device Registration Files
    • Device Design History Files
    • Device Production Files
    • Drug Production Files
    • Drug Site Master Files
    • Computer Systems and Software Validation
    • Validation of Production Systems and Laboratory Equipment

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