Product Overview
Performance Evaluation Report (PER)
We provide end-to-end Performance Evaluation Report (PER) services for in vitro diagnostic (IVD) medical devices to ensure compliance with EU IVDR 2017/746 and applicable global requirements. Our services cover the complete performance evaluation lifecycle, including development of the Performance Evaluation Plan (PEP); preparation of Scientific Validity (SVR), Analytical Performance (APR), and Clinical Performance (CPR) Reports; and execution of systematic literature searches aligned with IVDR and PRISMA requirements. We support IVDR readiness audits, technical file reviews, and performance gap analyses to identify and address compliance gaps, including planning for performance studies and post-market performance follow-up (PMPF) where required. Through close collaboration with your team, we strengthen device validation, mitigate regulatory risks, and support successful notified body submissions, enabling timely market access for safe, accurate, and clinically relevant IVD solutions.
Our Performance Evaluation services for IVD medical devices include:
– End-to-end Performance Evaluation Report (PER) support for IVD medical devices in compliance with EU IVDR 2017/746 and applicable global requirements
– Development of Performance Evaluation Plans (PEP) covering performance claims, acceptance criteria, and data sources
– Preparation of Scientific Validity Reports (SVR)
– Preparation of Analytical Performance Reports (APR)
– Preparation of Clinical Performance Reports (CPR)
– Systematic literature searches and reviews aligned with IVDR and PRISMA requirements
– IVDR readiness audits and technical file reviews
– Performance gap analysis and remediation support, including planning of performance studies
– Support for post-market performance follow-up (PMPF) activities
– Support for notified body submissions and conformity assessment activities
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