Clinical Evaluations – Strategic and Reliable

Take advantage of our 40 years of experience in the preclinical and clinical fields to secure your approval without unnecessary revisions.

Statistics show that most clinical evaluations do not yield the desired results on either the first or second attempt. The consequences are often endless, incomprehensible lists of objections from notified bodies, nerve-wracking delays, and unpredictable cost overruns.
It doesn’t have to be this way. I can help you proactively overcome these hurdles.
Every medical device is unique, and databases vary greatly. Based on your specific situation, I develop an effective and cost-efficient strategy for your clinical documentation.

To ensure that the approval process is focused and effective, I concentrate on the most important strategic points:

The success of a clinical evaluation depends largely on understanding the perspective of the assessors.

I, PD Dr. med. Ulrich Matern, combine four decades of experience in medical technology with the current perspective of notified bodies. Through my work as an assessor, current regulatory expectations are directly incorporated into the preparation of your documentation. The result is clinical evaluations that are not only formally correct but also navigate the review process without avoidable deviations. If you’d like to learn about the typical — and entirely avoidable — mistakes in clinical evaluation, you can find examples on my Reviewer's Blog or on LinkedIn. 

Let’s discuss how we can help you complete your clinical evaluation successfully, efficiently, and in full compliance with all regulatory requirements.