We create your clinical evaluation plan (CEP) so that you know exactly what to expect. This allows you to arrange any additional required pre-clinical tests, clinical studies, or investigations at an early stage and plan the resources needed.
With a well-founded clinical strategy, you can be sure that you are complying with all relevant requirements, e.g., MEDDEV 2.7/1, when developing your medical device.
Clinical investigations can disrupt schedules and budgets. Our experts can help you determine whether a clinical investigation is necessary before market approval.
Developing a clinical strategy is essential for the successful market launch of a medical device. However, in many cases, this fails due to inadequate planning:
Suddenly, e.g., a clinical investigation is necessary after all, and the costs cannot be borne, or critical advertising claims are made contrary to the intended purpose, which, in the worst case, costs you approval.
With a sound clinical strategy, you can avoid such pitfalls.
Our clinical affairs team will help you to develop a tailor-made clinical strategy.
Together with you, we proceed as follows:
Get in touch now to find the best clinical strategy for your medical devices together.
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We help you to pass approvals, audits, and reviews quickly and safely with legally compliant clinical evaluations.
With our support, you can ensure the quality of your clinical study or investigation and its results.
Discover the Guided Clinical Evaluator, your solution for the autonomous creation of clinical evaluations.
Our support does not end with approval. We are also at your side in the areas of post-market surveillance (PMS) and post-market clinical follow-up (PMCF).
Automate your post-market surveillance: We take over the continuous monitoring of the relevant notifications for your devices.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops put you on equal footing with experts.
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