May 21, 2013

Five Classifications for Risk Control Measures in Medical Device Development

Application Lifecycle Management
Security & Compliance

All risk control measures are not created equal. If you're looking for expert insight into the most effective risk control measures for your medical device, the following video is a great place to start. Dr. David Vogel of Intertech Engineering runs down his classification of software risk control measures, and provides specific examples on when each type of risk control is best used.

  1. Inherently safe design—global design requirements or constraints that render the potential hazard or harm all but impossible.
  2. Preventative controls—requirements and constraints that help to prevent a hazardous or harmful situation from materializing.
  3. Corrective actions—"detect and correct" risk control measures take a corrective action when a hazardous situation is detected.
  4. Mitigate—the severity of harm resulting from a hazard is reduced, but not necessarily eliminated.
  5. Soft controls—labeling, training, and operator instructions This is a short excerpt from our recent Leveraging Traceability in Your Risk Management Strategy webinar. Click the link to watch the entire webinar.