Experience that makes the difference.
Matern Consulting is led by PD Dr. med. Ulrich Matern. With a career spanning over 40 years across clinical practice, academia, and the medical device industry, I offer expert insights rooted in decades of hands-on experience. My work has actively shaped the fields of preclinical testing and clinical trials. I share my current findings from drafting and reviewing Clinical Evaluations in my Reviewer’s Blog.
Understanding the Standards of Notified Bodies
“In today’s MDR regulatory landscape, the Clinical Evaluation is the cornerstone of market authorization. However, the requirements are rigorous and often difficult to interpret.
What makes my work particularly valuable to you: I have first-hand knowledge of what reviewers are looking for. For over a year, I have served as an external reviewer for several Notified Bodies, assessing Clinical Evaluations for MDR compliance.”
This role provides me with deep insights into current MDR interpretations and the typical pitfalls that lead to deficiencies. My goal is to deliver documentation that passes the review process smoothly, without time-consuming non-conformities.”
My Philosophy: A peer-to-peer partnership
I do not view myself as a mere technical writing service, but as your strategic partner. I listen, precisely analyze your existing data, and develop a clinical argument that is technically and scientifically sound. Integrity, transparency, and clear communication are the foundation of our collaboration.