Risk Management Goodness

How to: Prepare for Risk Management Questions 

Emergo recently posted a top five issues list describing some of the common questions manufacturers have when it comes to risk management per ISO 14971 (the international risk management standard approved by the FDA as a consensus standard). The information contained in the list addresses topics not frequently discussed in risk management blogs. Realtime has created and analyzed a lot of risk management documentation for everything from cameras used to observe the knee joint during surgery, to ophthalmic lasers in LASIK procedures. And in the spirit of providing useful lists, we thought we’d identify a few of the good things we’ve seen.

Here’s what to prepare as you head into the manufacturing portion of your product’s life cycle.


  • Have a standardized list of harms and associated severities to ensure consistency.
  • Have a consistent risk management file allowing harms identified in the hazard analysis to be linked to root causes identified in the FMEAs and other bottom-up analyses.
  • Explicitly state (either in the analysis documents or in the risk management report) when risk items called out by the standards (60601-1, 14971, etc.) do not apply. This makes auditing a lot easier.
  • Create risk controls to prevent the cause of the hazard. These risk controls are frequently inherent safety by design and manufacturing and to prevent hazardous situations.
  • Analyze each combination of cause, hazard, hazardous situation, and harm as a separate line item. This provides better insight into how best to manage the individual causes and hazardous situations that may arise. This process also helps assess the residual risk after implementing risk controls.

As a device manufacturer, the FDA and other regulatory bodies charge you with producing safe and effective products. Realtime’s holistic approach to risk management can help make your product as safe as possible. With our design engineers’ expertise in mechanical, electrical, and software, we can also help your product meet its design specifications.