Medical Products Validation & Performance Study
Medical Products Validation & Performance Study
According to the current IVDR regulations, performance improvement studies should be conducted after the product enters the market.
Association of an analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.
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IVDR Article 2(44)
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IVDR Article 2(44)
The performance study contains 3 terms: Scientific validity，analytical performance and clinical performance.
Association of an analysis with a clinical condition or a physiological state.
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IVDR Article 2(39)
Means the ability of a device to correctly detect or measure a particular analyte.
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IVDR Article 2(40)
Ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.
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IVDR Article 2(39)
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IVDR Article 2(39)
Means the ability of a device to correctly detect or measure a particular analyte.
-
IVDR Article 2(40)
Ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.
-
IVDR Article 2(39)
Product Validation
Validation is part of the product certification, the purpose of which is to ensure that the products can achieve their described effects.
We assist our customers in the validation of their products, which encompasses analytical sensitivity, accuracy (bias), precision (repeatability as well as reproducibility), accuracy (analytical performance and clinical), detection and quantification limits, linearity, sample handling, interfering substances (endogenous and exogenous), cross-reactivity, etc.
Performing performance verification will not only improve the credibility of your product, but will also reduce the risk of future problems with your product. If you would like to have your product validated, please contact us.
We assist our customers in the validation of their products, which encompasses analytical sensitivity, accuracy (bias), precision (repeatability as well as reproducibility), accuracy (analytical performance and clinical), detection and quantification limits, linearity, sample handling, interfering substances (endogenous and exogenous), cross-reactivity, etc.
Performing performance verification will not only improve the credibility of your product, but will also reduce the risk of future problems with your product. If you would like to have your product validated, please contact us.
Other Services
Our lab provides other services, such as national reference laboratory comparison experiments and interlaboratory comparisons. In a nutshell, we’re dedicated to improving the recognition and competitiveness of your products.
