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Ron Gerner
Regulated Software and Quality Systems

Over the past twenty five years, Ron Gerner has held positions in software engineering, information technology, quality engineering and quality management.

His areas of expertise include:

  • Compliance to FDA regulations and ISO requirements
  • Software quality assurance
  • Design control
  • Process and product assessments
  • Software process definition and improvement
  • Root cause analysis
  • Defect analysis and resolution
  • Quality system auditing
  • Risk management
  • Supplier quality assurance
  • IT project management
  • Computerized system validation
  • 21 CFR Part 11
  • 510k and PMA technical documentation
  • Complaint handling
  • Training
  • Document management
  • Ron holds a BS in computer science with a minor in economics from Northern Illinois University.

    He is a memeber of the AAMI Medical Device Software Committee and holds certifications as:

  • ASQ Certified Software Quality Assurance Engineer (CSQE)
  • ASQ Certified Quality Auditor (CQA)
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    Dr. Maret Maxwell PMP
    214-452-1721

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