With the implementation of the IVDR you will need to provide CLINICAL EVIDENCE that your device is fit to fulfil its intended purpose. SCIENTIFIC VALIDITY, ANALYTICAL PERFORMANCE, and CLINICAL PERFORMANCE have to be proven by clinical investigations and presented in a PERFORMANCE EVALUATION REPORT. This is one of the main reasons for the concerns of smaller diagnostic companies regarding the year 2022.
ICS will plan, conduct, and evaluate these studies for you!
UPDATE: CORONA VIRUS
Naturally, our services apply for SARS-CoV-2 IVDs as well!
You want a performance assessment of a SARS-CoV-2 assay or even a complete validation? We are ready to do our share. Let us conduct the necessary performance studies that prove the quality of your test and be among the first manufacturers that offer a state-of-the-art CE-certified SARS-CoV-2 IVD!
An Analytical Performance Study assesses the ability of a device to correctly measure the corresponding analyte.
Using state-of-the-art approaches and following the corresponding guidelines (e.g. CLSI) we will take care of all necessary steps:
- Procurement of samples
- Assessment of all parameters described in IVDR, annex I, Section 9.1, point (a)
- Detection and quantification limits
- Intererences and cross-reactivity
- Trueness (Bias)
- Precision (Repeatability and reproducibility)
- Measuring range
- Specimen collection and handling criteria
- Generation of the Analytical Performance Study Report according to IVDR, annex XIII, part A.
- Application to an ethics committee
- Sample procurement
- Clinical Performance Study Plan according to ISO 20196 and IVDR, annex XIII, part A
- Study site recruitment and monitoring
- Statistical analysis
- Clinical Performance Study Report according to ISO 20196 and IVDR, annex XIII, part A