Risk-based test

RISK-BASED TEST
– A SPECIALITY FROM ELDOTEK

Risk analysis: ”foresee user risks”

  • define user safety
  • conduct user risk analysis
  • include risk mitigations in product requirements

riskvmodel325_88

Process control: ”manage user risks”

  • perform requirement management (tracing)
  • perform configuration control
  • conclude by risk-based testing

Risk-based test design

  • include user risk analysis
  • include risk mitigations
  • do requirements include risk?

Risk-based testing

  • make sure to understand the risks
  • make sure to understand the mitigations
  • open your mind
  • put yourself in the user’s place

 

VALIDATION OF MEDICAL SOFTWARE
– BASIC CONTRIBUTION OF ELDOTEK

First of all, find “Level of Concern”

Health authorities focus on risk for user

FUNCTIONAL SAFETY SOFTWARE
– ANOTHER CONTRIBUTION OF ELDOTEK

Functional safety of safety-related systemS

which indicates how seriously the product can influence on the user’s health

  • minor level of concern (product failure results in no injury to the user)
  • medium level of concern (product failure results in non-serious injury to the user)
  • major level of concern (product failure results in user death or serious injury)

FDA: Guidance for Industry, 510(k) Submissions, 2010 – key issues:

  • Device description
  • Risks to health
  • Assurance case report
  • Clinical evaluation
  • Risk management
  • 510(K) pre-clearance inspection
  • Labeling
  • Postmarket surveillance

IEC: Functional Safety, IEC61508 – key issues:

  • Hardware safety
  • Software safety
  • Risk management