"The last step before customer release"Instrument and/or process validation in compliance with the IVD standard regulations in various fields : Analytical : - Statistical analysis of the results,
- Linearity range (IVD conformity),
- Correlation,
- Stability,
- Contamination,
- Reagent validation.
Software : - Test plan and procedure implementation (system test, regression test, stress test …),
- Highlight and follow-up the bugs,
- Suitable operating of the system,
- Knowing the system limits,
- Test tool development.
Physical tests : - Simulation of extreme conditions,
- Completion of thermal and climatic tests,
- Performance and reliability tests,
- Subsets test,
- Bench of test creation.
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