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Event Info

Q1 Productions 6th Semi-Annual Medical Device Sterilization Conference

October 29 – 30, 2019 | Arlington, VA

Industry collaboration & consensus on Ethylene Oxide Residual Reduction, Risk-Based Approaches to Selection & Validation of Sterilization Modality to meet increasingly complex regulatory requirements include FDA parametric release, numerous ISO standards and EU MDR.

 

Core Topics to Address

  • Future of Ethylene Oxide (EtO) sterilization in light of residual concerns
  • Future of Ethylene Oxide (EtO) sterilization in light of residual concerns
  • Alignment of sterilization process & validation with regulatory requirements
    • FDA regulatory requirements & achieving parametric release
    • ISO risk assessment, residual and biocompatibility standards
    • EU MDR focus on conservative approach to residual limits
  • Biocompatibility, sensitivity testing, residuals & risk assessment
  • Development of comprehensive sterilization IFUs for reusable devices
  • Evolution of quality systems: Validating new cycles & process equivalency
  • Lifecycle approaches to device sterilization from development to post-market