Clinical affairs teams are often under great pressure: Notified bodies demand short-term revisions of clinical evaluations, while the team struggles with regulatory uncertainty and a lack of clinical data.
In addition, there is often the worry of delaying market launches or being perceived as an obstacle within the company.
Our experts take the pressure off clinical affairs teams and help companies act safely and efficiently.
Precision counts when it comes to audits and reviews. Our experts are known for their high-quality clinical evaluations – even at notified bodies.
Our clinical evaluations are not only precise but also understandable, which means fewer corrections for you. You can also update the documents yourself and use them as samples for other devices.
The speed with which we write and review clinical evaluation files impresses many manufacturers. The result: accelerated approval for your devices.
Non-conformities affect not only clinical evaluations but also risk management and biocompatibility, for example. Together, our over hundred experts help to solve the problems holistically, quickly, and coordinated.
Whether substance-based medical devices, AI software, or active implants – our team covers all specialist areas and product types. Authorities and notified bodies also value our expertise.
Our team does not simply work through clinical evaluations. We prepare you proactively and strategically for future devices, product variants, and legislative changes – with an international perspective.
We are happy to support you in effectively carrying out your literature search, check your previous methods and results, and, if necessary, give you improvement tips.
We can help you prepare the scientific validity report or check your existing report for conformity.
Our clinical affairs team supports you in writing, reviewing, and updating clinical evaluation plans (CEP) and reports (CER). The result: compliant clinical evaluation files that will help you impress in audits and reviews!
We also support you in post-market clinical follow-up (PMCF): from creating PMCF plans to collecting and evaluating post-market data and creating PMCF reports – we keep your clinical evaluation file up-to-date and compliant at all times.
Our clinical affairs team is ready to support you! Contact us.
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+49 7531 94500 20
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We help you develop an optimal clinical strategy, so you know what to expect during the clinical evaluation.
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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