Quality Services

Quality and compliance are the cornerstones of the life sciences industry, and ECI's practices serve a wide variety of client needs in these areas. Partner with us to minimize audit findings, 483s, and warning letters related to quality system issues.

Our robust audit services can support internal, supplier, mock FDA, EUMDR, and IVDR audits to identify quality system deficiencies and help ensure you are prepared for outside audits when the time comes.

Lean on our experienced, certified auditors for support for everything from project-based solutions to broader strategic services that help ensure compliance with regulations and standards across all areas of your global quality system.

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By the Numbers

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14

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30

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Our Capabilities

Quality System Development

  • Quality System Regulations (QSR)
  • Current Good Manufacturing Practice (cGMP)
  • ISO 13485:2016
  • EU MDR
  • EU IVDR

Quality Assurance

  • Design Quality Assurance (DQA)
  • Quality Engineering (QE)
  • Supplier Quality Engineering (SQE)
  • Quality Systems Support
    • Nonconformance (NC)
    • Corrective and Preventive Actions (CAPA)
    • Supplier Corrective Action Request (SCAR)
  • Design Quality Assurance (DQA)
  • Quality Engineering (QE)
  • Supplier Quality Engineering (SQE)
  • Quality Systems Support
  • Nonconformance (NC)
  • Corrective and Preventative Actions (CAPA)
  • Supplier Corrective Action Request (SCAR)

Audit and Inspection Management and Support

  • Internal/External Audits
  • Supplier Audit
  • MDSAP Audit
  • FDA Mock Inspection
  • Audit Inspection Readiness Training

Impact That’s Tangible

Why not see for yourself the value ECI provides to clients through quality services? Find insight about how we support our customers through case studies specific to quality engineering.

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Quality Case Study

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Quality Case Study

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Quality Case Study

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Quality Case Study

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Quality Case Study

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Quality Case Study

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Our Strategic Services

Looking for support outside of regulatory compliance? Our team is here to expertly guide you through every product lifecycle challenge you may encounter. Learn more about our other service offerings through the link below.

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Let Us Help

You focus on your business. We focus on the momentum of the industry and help you keep pace across your portfolio.

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