In vitro diagnostic (IVD) devices are medical devices and tests that analyse human samples outside the body, providing critical information for disease diagnosis, monitoring, and treatment. Performance evaluation studies are used to demonstrate conformity to safety and performance requiremeIn vitro diagnostic (IVD) devices are medical devices and tests that analyse human samples outside the body, providing critical information for disease diagnosis, monitoring, and treatment. Performance evaluation studies are used to demonstrate conformity to safety and performance requirements with respect to its intended purpose. A Performance Evaluation Report (PER) is comprehensive document that summarizes the outcomes and findings of the performance evaluation of an IVD device. The PER report is a critical component of the regulatory submission for an IVD, providing evidence of its analytical and clinical performance, to be approved for release onto the market. The requirements for performance evaluation in the EU are described in the In Vitro Diagnostic Regulation (EU 2017/746).nts with respect to its intended purpose.
At PeploBio we understand how challenging and time consuming it can be for IVD manufacturers to navigate a shifting regulatory landscape. That is why we make it our mission to work alongside our clients to make the IVD performance evaluation process seamless. Below are the types of services we offer.
Our study plans provide a comprehensive description of each performance evaluation study; from objectives, timelines, budget, participant selection and recruitment, methodology and materials, procedures, metrics, data collection, data analysis to reporting. Our processes are administered and approved by qualified experts with doctoral degrees and HCPC registration to ensure our services are of the highest quality. To provide a seamless performance evaluation process, we also support other complementary services such as biospecimen sourcing, temperature-controlled transport, and clinical trial patient recruitment.
Analytical performance aims to assess the performance metrics of an IVD in detecting or measuring its target analytes or markers. Analytical performance studies measures parameters such as precision, accuracy, linearity, analytical sensitivity, and specificity in a controlled laboratory setting.
Clinical performance studies evaluate the diagnostic accuracy, such as sensitivity, specificity, positive predictive value, and negative predictive value, and overall effectiveness of the IVD in identifying specific conditions or markers in a clinical context. This assessment aims to mimic the conditions under which the diagnostic test will be used by a diverse patient population.
Usability studies assess the user experience, with a focus on user interface, ease of use, and overall user experience, when interacting with an IVD. Participants are typically representative of the target user population, and the study may involve individuals with varying levels of experience and expertise. Usability study data is used to optimize the design of the IVD, packaging and instructions for use to improve user experience.
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