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
– BASIC CONTRIBUTION OF ELDOTEK
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
– ANOTHER CONTRIBUTION OF ELDOTEK
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
Got any questions?