Quality and Compliance

Target Zero Rework

Today, effective quality practices have involved formalizing a process after a quality issue has been found or raised. These issues come from the field, or from the development and launch process itself. Some solutions focus on the various tools for quality issue prevention, such as Quality Functional Deployment (QFD), Failure Mode and Effect Analysis (FMEA), etc. These disciplines and processes have been touted as the mechanism for issue prevention and quality improvement for years.

Key benefits

  • Extend compliance data to a broader audience, allowing for more effective decisions and awareness
  • Integrate supplier declarations early into the product development 
  • Design in material compliance and monitor in real-time
  • Establish end-to-end traceability during the development process that can be leveraged for impact analysis

ROLES AND OPTIONS

  • Materials Compliance Manager

    Manage Full Range of Products Environmental Compliance Information and Material Regulations

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  • Supplier Materials Compliance Engineer

    Gathering Material Declarations From the Supply Chain for Outsourced Parts in Products

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  • Materials Compliance Analysis

    Monitor, Analyze and Control Materials Compliance Information for Better Decision Making

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  • Quality Manager

    Integrated Closed-Loop System for Full Range of Quality Management From Non-Conformance Reports to Corrective and Preventative Actions

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  • Quality Document Manager

    Document Management for Enterprise-Wide Collaboration While Ensuring Regulatory Compliance

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  • Device Master Record Manager

    Provides a "Living" DMR for Full Traceability and Automated reporting

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  • Regulatory Affairs Manager

    Expedite Premarket Approval With Efficient Document Submissions

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