We create your device-specific performance evaluation plan and define the level of evidence to be provided so that you know exactly what you have to do. That allows you to plan the necessary analytical and clinical investigations at an early stage and estimate the required resources, efforts, and costs.
With a well-founded performance evaluation strategy, you can be sure of complying with all the relevant IVDR requirements when developing your IVD medical device. This will ensure a successful approval process.
Extensive performance studies can disrupt schedules and budgets. Our experts help you determine whether and to what extent analytical and clinical performance studies are necessary before market approval.
Developing a device-specific IVD performance evaluation strategy is essential for a fast and successful market launch. However, in many cases, it fails due to inadequate intended purpose and/or planning:
Suddenly, e.g., a more extensive performance study is needed, and the costs cannot be borne, or the intended purpose was not formulated precisely enough so the results cannot be used in the end.
With a sound performance evaluation strategy, you can avoid such pitfalls.
Our IVD team will help you to develop a tailor-made performance evaluation strategy.
Together with you, we proceed as follows:
Contact us now to find the best strategy for your performance evaluation.
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We help you to pass the approval, audits, and technical reviews quickly and safely with legally compliant performance evaluation files.
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.
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