Performance evaluation is a central process that accompanies the entire life cycle of an IVD medical device. It begins with the formulation of the intended purpose, continues with the determination of the state of the art, covers the proof of scientific validity, includes analytical and clinical performance studies, encompasses the benefit-risk assessment before initial placing on the market, and continues during the continuous monitoring of the safety and performance of an IVD.
Accordingly, the legal requirements for performance evaluation are stringent. Many IVD manufacturers and health institutions, such as medical laboratories, struggle to understand and implement them: They don't know where to start, how to systematically search for and evaluate existing data, which performance studies they need to plan, or how to document the results in a regulatory-compliant manner.
Precision and objective, soundly reasoned evidence count in audits and reviews. Our experts are known for their high-quality and well-founded performance evaluation files, also at the notified bodies.
Thanks to our structured templates, our performance evaluation documentation is not only precise but also comprehensible and regulatory compliant. That means less rework for you. In addition, you can update the documents yourself and use them as templates for other devices.
Whether reagent kits, IVD assays, IVD devices, or IVD software – our team covers all specialties and product types. Our expertise is also valued by authorities and notified bodies.
We turn the creation of your performance evaluation file into a sprint. The result is accelerated approval of your devices and, thus, earlier revenues.
You can sit back and relax: Our team can take over the entire project management – from strategy development and study planning to the final performance evaluation.
Deviations not only affect performance evaluation but also risk management and usability, for example. Our team of over a hundred experts works together to solve problems quickly, in a coordinated manner, and from a holistic perspective.
We are happy to support you in effectively conducting your literature research on the state of the art and documenting it compliantly. We can also review your previous methods and results and provide tips for improvement.
We help you with systematic literature research and creating a report to prove scientific validity. We can also check your existing report for conformity.
We support you in writing, reviewing, and updating the performance evaluation plan (PEP), the analytical performance report, the clinical performance report, and compiling the performance evaluation report (PER). The result: compliant and strategically well-founded performance evaluation documents that you can use to impress in audits and technical reviews!
We also help you with post-market performance follow-up (PMPF): From developing PMPF plans and collecting and evaluating post-market data to PMPF reports, we keep your performance evaluation file up to date and in compliance.
Our expert team is ready to support you! Get in touch.
Phone
+49 7531 94500 20
Contact Form
We help you develop an optimal performance evaluation strategy that precisely matches the intended purpose of your IVD. That gives you certainty about what to expect during the performance evaluation.
With our support, you can ensure the quality of your analytical and clinical performance studies and their results.
Our support does not end with approval. We are also at your side in the areas of post-market surveillance (PMS) and post-market performance follow-up (PMPF).
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops put you on equal footing with experts.
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
