Statistical Techniques for Medical Device Manufacturers

Statistical Techniques for Medical Device Manufacturers is a conference that covers topics such as:

  • How to apply the FDA tools to develop a clear understanding of the requirements.
    • Preamble
    • Regulation
    • QSIT
    • Small Entity Compliance Guide
    • Warning Letters
  • The sections of FDA QSR that require statistical techniques
  • How to implement and apply the ISO/TR 10017 statistical techniques
  • The set of statistical techniques in ISO/TR 10017

Statistical Techniques for Medical Device Manufacturers brings together:

  • Quality Engineers
  • Quality Managers
  • Regulatory Affairs Managers
  • Quality Assurance and Quality Control
  • R&D Managers
  • Regulatory Affairs Professionals
  • Product Design and Development
  • R&D Engineers
  • Production Managers and Supervisors
  • Operations Managers
  • Risk Managers
  • Manufacturing Engineers
  • CAPA team members
  • Complaint system team members

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