Performance evaluation has the same objective as clinical investigation of any other medical device: Based on performance data, both the requirements relevant to performance and the assessment of risks and the acceptance of the benefit/risk ratio must be demonstrated. These performance data include information on the analytical performance and clinical performance of the device. The analytical performance demonstrates the ability of your device to correctly detect or measure a particular analyte.If you are fit in verification, you have a lot of potential to use synergies and thus save costs.Talk to us! Our team will be happy to support you.
Verification
Verification demonstrates that your product was developed and built correctly and is thus an essential part of the development of any IVD medical device.
Parameters for demonstrating a device’s analytical performance[
According to IVDR Annex I Section 9.1a, the determination of the following parameters is considered analytical performance:
All the parameters described must be considered unless any omission can be justified as not applicable.
- analytical sensitivity,
- analytical specificity,
- trueness (bias),
- precision (repeatability and reproducibility),
- accuracy (resulting from trueness and precision),
- limits of detection and quantitation,
- measuring range,
- linearity,
- cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference,
- cross-reactions
All the parameters described must be considered unless any omission can be justified as not applicable.
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