There is no need to sweat when audits or reviews are pending: We help you prepare your data collection and performance studies in accordance with requirements and document them in a regulatory-compliant manner.
Through targeted planning and preparation, we can minimize the effort required for the studies and the associated costs so that the expenses for the performance studies do not prevent you from getting your approval.
Whether reagent kits, IVD assays, IVD devices, or IVD software – our team covers all specialties, methods, and product types. Our expertise is also valued by authorities and notified bodies.
IVD manufacturers and health institutions, such as medical laboratories, must systematically collect and evaluate analytical and clinical data to fully demonstrate the safety and performance of an in vitro diagnostic medical device (IVD).
Unfortunately, clinical evidence sometimes requires the documentation of a large number of analytical and clinical performance parameters, which means that these have to be collected in often costly studies.
Contact us if we can help you plan and implement your analytical and clinical performance studies.
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We help you develop an optimal performance evaluation strategy that precisely matches the intended purpose of your IVD medical device. This gives you certainty about what to expect during the performance evaluation.
We help you pass the approval, audits, and technical reviews quickly and safely with legally compliant performance evaluation files.
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.
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