For medical devices to be used in clinical settings, certain regulatory standards must be met. PeploBio is committed to supporting manufacturers to place in vitro diagnostics on the market. We offer third-party clinical performance evaluations at our ISO 15189 accredited clinical laboratory, as part of our end-to-end regulatory support, supporting manufactures to comply with regulations including CE-IVDR, FDA & CTDA.
A clinical performance evaluation of a medical device describes the process of assessing the safety and performance of the medical device when used as intended by the manufacturer. Performing a clinical evaluation study is one way to demonstrate that a medical device meets the standards required by regulators and is safe and effective. The study will demonstrate scientific validity, analytical performance and clinical performance of the device. The evidence and statistical data produced throughout the duration of the study can be used to identify areas of improvement in the device design for research and development purposes. Clinical performance evaluation studies are also a valuable marketing and sales tool to illustrate superiority of clinical application capacity, in comparison to other medical devices on the market.
We have supported numerous manufacturers by performing Clinical Performance Evaluation Studies for rapid tests, POCT devices, molecular assays and immunoassays (ELISA). We are able to provide full clinical evaluation services including designing and writing the Study Plan, sourcing of clinical samples, compiling a systematic literature review, limit of detection calculations using reference material and performance comparisons against a gold standard to determine assay sensitivity and specificity. At PeploBio we specialise in molecular and immunoassay technologies.
Regulatory compliance: the study plan is designed with the intended certification in mind (including FDA & IVDR) to ensure that the device meets all applicable regulatory standards. Having a third-party evaluation demonstrates to the regulatory a commitment to an objective and comprehensive evaluation of the medical device’s performance.
Credibility & trust: we are committed to maintaining high-quality standards demonstrated by our laboratory and QMS ISO 15189 accreditation.
Clinical expertise: our team of scientists include PhD and HCPC registered biomedical scientists, who provide comprehensive support from study initiation to submission of the clinical performance evaluation report to the regulator.
Access to biospecimens: we have an extensive network of biobanks across the NHS and UK, Europe, US and Asia with appropriate ethical documentation to accssess to patient samples including those from rare disease subtypes.
Get device usability feedback: the study can be designed to provide feedback from patients, healthcare professionals, as well as laboratory technicians.
Cost Effective: the well-established links between our clinical laboratory and suppliers allows us to pass on significant savings to our clients through economies of scale, when sourcing comparator assays and clinical specimens.
PeploBio is a UKAS accredited Medical Laboratory No. 22998. Our UKAS accredited ISO:15189 laboratory has robust quality processes in place, essential for supporting drug and vaccine discovery, validation, and development.
We are ICO registered organisation with clearly defined data privacy policies, and robust data protection systems to ensure third party patient data remains protected.