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Free Risk Management Templates

Written by Karl Larsson on . Posted in Tips & Tricks.

Risk Management is a crucial part of Medical Device Development and if you are about to develop a Medical Device, you and your team are likely to find yourselves spending many hours compiling Risk Assessments.

There exist several techniques for performing a proper Risk Assessment but they all follow the same basic steps:

  • Define your risk policy (risk acceptance criteria)
  • Identify the Hazards through a structured analysis
  • Evaluate the Risks by estimating severities and probability
  • Mitigate the Risks that are not acceptable
  • Implement and verify the mitigations for effectiveness

To get you started, we have made two free Risk Assessment Excel templates available for download.

Download Free Risk Assessment Templates

The first demonstrates a Failuremode and Effect Analysis (FMEA) approach, a widespread technique used in many areas and industries. We often see it in bottom-up types of Risk Assessment.

The second one uses a Preliminary Hazard Analysis (PHA) approach which is an excellent top-down approach earlier in the design cycle where many of the design details are not yet known.

Both these techniques are available in Aligned Elements and we have compared and contrasted them in earlier posts.