July 25, 2013

Pragmatic Medical Device Risk Management Presentation

In this presentation, which was recorded at the 2013 Medical Devices Summit West in San Francisco, David Vogel of Intertech Engineering and Aimee Raymond of Cordis discuss some current problems and solutions in medical device development, including how to:
  • Manage the real hierarchy of harms, hazards, and causes
  • Prioritize and manage risk
  • Implement traceability to ensure risk controls have been implemented correctly
  • Deal with overall risk assessment and residual risk