About the Conference

“The word ‘risk’ is thrown at me from a lot of different directions, with a lot of different definitions.  How do I deal with it?”

Sound familiar?

              There is product risk, patient risk, and enterprise risk.  It is increasingly difficult for med tech manufacturers to comply with the growing array of existing and new US and OUS regulations, guidances, and standards, and to understand the tools and best practices for the effective application of risk principles throughout the product life cycle.

Run by recognized risk experts in the med tech field, this conference focuses on the practical understanding and application of risk management for manufacturers of medical devices, diagnostics, and combination products.


Who should attend:

  • Risk management
  • Compliance
  • Executive management
  • R&D
  • Regulatory affairs
  • Quality assurance
  • Supply chain management
  • Software
  • Medical / patient safety


What you will learn:

  • The efficient and effective application of risk management concepts and tools
  • Trends in medical product risk management
  • Overview of risk management regulations and standards
  • Determining risk acceptability
  • Addressing residual risk
  • Risk management in product development
  • Risk management and the Quality System
  • Enterprise risk management
  • Risk management maturity models
  • End user perspectives on risk
  • Maintaining and updating risk files
  • Remediation of legacy product risk files
  • Risk management applied to connected devices and systems
  • Diagnostics risk management
  • Software risk management
  • Combination product risk management



CEU Information

Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.


  • When

  • Wednesday, November 8, 2017 - Thursday, November 9, 2017
    8:00 AM - 3:30 PM

  • Where

  • Hogan Lovells
    555 Thirteenth Street, NW
    Washington, DC 20004

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