Biomedical Engineer how-to

How to Run a Device Risk Analysis

Risk analysis protects patients.

Updated By the Career Education Institute Curriculum Team
Quick answer

Risk analysis protects patients. In short: list; find; rate, then complete the remaining steps below.

Step by step

  1. List hazards.

  2. Find causes.

  3. Rate severity.

  4. Rate probability.

  5. Add controls.

  6. Re-rate risks.

Safety reminders for biomedical engineers

  • Follow lab safety
  • Follow biosafety rules
  • Protect patient data
  • Design for patient safety

ABET · PE license · FE exam · CAD · Specification · FDA: see the full biomedical engineer glossary.

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