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5th Annual Medical Device Sterilization Conference

September 24-25, 2018
Minneapolis, MN

Millennium Minneapolis Hotel

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ABOUT THE CONFERENCE

Across the medical device industry, executives responsible for product sterilization are continually evaluating processes and validation methodologies to ensure cycle optimization while maintaining device sterility for enhanced patient safety. As devices are becoming increasingly complex, ensuring the appropriate sterilization method is selected and properly validated is of utmost importance to maintain compliance. As such, alignment to key regulatory bodies’ expectations through the use of internationally recognized standards, including AAMI and ISO remains critical to the success of timely validation submissions and approvals. Additional regulatory scrutiny will be given to the dissonance between governing bodies in the United States and Europe surrounding both Ethylene Oxide residuals and reusable devices.

The Q1 Productions 5th Annual Medical Device Sterilization Conference will bring together industry leaders, regulatory bodies and solution providers to discuss topics of key importance and timely concern. Via a mix of formats including panel discussions, exchange groups, workshops and traditional presentations, attendees have the opportunity to take away actionable content through engaging sessions and the sharing of best practices. Further and as always, the event will offer a unique networking platform for delegates to connect with a multitude of key experts in the field.

TOPICS TO BE ADDRESSED:

  • Selecting an appropriate test method for sterility validation
  • Interpretation of reusable device standards in both the US and abroad
  • Application of standards language for sterilization validation submissions
  • Establishing open lines of communication between R&D and sterilization
  • Sterilization compliance opportunities for multiple markets via the MDSAP
  • Addressing acceptable Ethylene Oxide residual levels in France vs. FDA/AAMI
  • Providing appropriate cleaning instructions to hospital and healthcare facilities
  • Partnering directly with contract sterilizers to establish sufficient capacity levels
  • Exploring novel sterilization methods for increasingly complex medical products
  • Appropriate sterilization method selection for enhanced safety and cost-savings
  • Diverse representation, including notified bodies, discussing regulatory concerns abroad
  • Tackling the change in FDA biocompatibility expectations through product chemical analysis
  • Ensuring the safety of reusable devices through both high-level disinfection and sterilization
  • Company-specific case studies for real-world process and cycle optimization of sterilization modalities

ABOUT THE CONFERENCE

The Q1 Productions 5th Annual Medical Device Sterilization Conference will bring together industry leaders, regulatory bodies and solution providers to discuss topics of key importance and timely concern. Via a mix of formats including panel discussions, exchange groups, workshops and traditional presentations, attendees have the opportunity to take away actionable content through engaging sessions and the sharing of best practices. Further and as always, the event will offer a unique networking platform for delegates to connect with a multitude of key experts in the field.

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