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Regulatory affairs

Performance evaluations (IVD)

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Performance evaluations (IVD)

Whether you need end-to-end support or assistance with specific activities, our staff is here to ensure your performance evaluations are conducted efficiently and effectively. Our team brings together a wealth of cross-disciplinary expertise encompassing scientific, clinical, and regulatory fields. We’re here to support you in conducting performance evaluations of In Vitro Diagnostic Devices (IVDs), aligning with the requirements of the In Vitro Diagnostic Devices Regulation (IVDR, 2017/746).

With our assistance, you can confidently prepare comprehensive Performance Evaluation Plans (PEPs) and Reports (PERs) tailored to your specific needs and regulatory obligations. Additionally, our team is available to independently verify previously conducted performance evaluations for IVDs. We can also help you develop specific scientific and clinical rationale needed for regulatory purposes, or assist with individual tasks related to performance evaluations, such as literature searches.

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