Clinical Evaluation
Clinical evaluations made easy:
Fast and safe through approvals, audits, and reviews
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.
Safety in audits
Precision counts when it comes to audits and reviews. Our experts are known for their high-quality clinical evaluations - even at notified bodies.
Less long term effort
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.
Top expertise for all product types
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.
Comprehensive solutions from a single source
Non-conformities affect not only clinical evaluations but also risk management and biocompatibility, for example. Together, our more than one hundred experts help to solve the problems holistically, quickly, and coordinated.
Rapid implementation
The speed with which we write and review clinical evaluation files impresses many manufacturers. The result: accelerated approval for your devices.
Future-proof in all markets
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.
Our clinical affairs services: Comprehensive support for clinical evaluations for all medical devices and markets
Literature research on the state of the art
We will be happy to support you in effectively carrying out your literature search, check your previous methods and results, and, if necessary, give you improvement tips.
Proof of scientific validity
We can help you prepare the scientific validity report or check your existing report for conformity if required.
Clinical Evaluations
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 shine in audits and reviews!
Post-Market Clinical Follow-up
We also support you in the area of Post-Market Clinical Follow-up (PMCF): from creating PMCF plans to collecting and evaluating post-market data and PMCF reports - we keep your clinical evaluation file up-to-date and compliant at all times.
Further support for the clinical evaluation of your medical device
Clinical Strategy
We help you develop an optimal clinical strategy, so you know what to expect during the clinical evaluation.
Clinical Studies and Investigations
With our support, you can ensure the quality of your clinical study or investigation and its results.
Guided Clinical Evaluator
Discover the Guided Clinical Evaluator - your solution for the autonomous creation of clinical evaluations.
Post-Market Surveillance and Post-Market Clinical Follow-up
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).
Post-Market Radar
Automate your Post-Market Surveillance: We take over the continuous monitoring of the relevant notifications for your devices.
Seminars, and Workshops
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops allow you to talk to experts at eye level.
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