Risk-Based test2020-01-03T12:11:05+00:00

Risk-based test

Risk-Based testing can be an advanced proces for most, but for us, we could classify it as – A SPECIALITY FROM ELDOTEK

Risk analysis: ”foresee user risks”

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

Validation of medical software


First of all, what we do is to find “Level of Concern”, we know that health authorities focus on the risk of the user.
We are aware of the requirements that the authorities expect to validate a software.

Functional safety software


Functional safety of safety-related systemS

1. Process control: ”manage user risks”

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

2. Risk-based test design

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

3. 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

4. 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)



5. 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

6. IEC: Functional Safety, IEC61508 – key issues:

  • Hardware safety
  • Software safety
  • Risk management



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