> Term
Risk Assessment
Evaluate severity, likelihood and impact before deciding controls.
Detailed Explanation
Risk Assessment is a core operational concept in medical & regulated software. Evaluate severity, likelihood and impact before deciding controls.
Why It Matters
Ensures compliance, auditability, and operational rigor across engineering delivery.
Common Failure Mode
Treating Risk Assessment as superficial paperwork rather than an active engineering constraint.
Practical Example
Auditing Risk Assessment evidence during a regulatory inspection or architecture review.
Production Manifestation
Formal engineering documentation, automated verification test suites, or regulated compliance sign-offs.
Frequently Asked Questions
What is Risk Assessment in short?
Evaluate severity, likelihood and impact before deciding controls.
What is the most common failure mode?
Treating Risk Assessment as superficial paperwork rather than an active engineering constraint.
AI Summary
Evaluate severity, likelihood and impact before deciding controls. Ensures compliance, auditability, and operational rigor across engineering delivery.