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The safety of medical device users is of utmost importance to me. I have a very analytical and focused way of working. As a result, I can not only efficiently support medical device manufacturers in the approval and further certification of their products, but also contribute to ensuring patient safety.


Dr. Claudia Kleinhans

SCIENTIFIC & REGULATORY EXPERT


TOP SKILLS: Clinical Evaluation, Biological Evaluation, Risk Management


Why PRO-LIANCE
Working at PRO-LIANCE allows me to support medical device manufacturers in the preparation of clinical evaluations, risk management documents and help with regulatory aspects. However, it also helps me to develop my own skills in these areas continuously so that I can always produce high quality work.

Challenges
What makes this work both challenging and enjoyable at the same time for me is the fact that it offers so much diversity. The products I assess cover a wide range of applications. However, at the end of the day, it doesn’t matter whether it’s an acupuncture needle, an infusion pump to a beauty filler- all products have one thing in common: they all have to meet essential requirements and deliver performance and safety. Each customer is different, too, and so is each notified body. Meeting the different requirements, wishes and tasks is what spurs me on and motivates me to produce highly-qualified clinical evaluations.

My strengths
As a biologist with a PhD and looking back on many years of working in the scientific field, I quickly realized that my strengths lie in analyzing, writing, summarizing, evaluating and that I have particularly keen interest in medical issues.

My motivation
At the end of the day, each time I finish a clinical evaluation and check the formatting one more time – it pleases me almost as much as back when I was finalizing my PhD thesis.

Who I am
Being a biologist at heart, in my spare time, I can usually be found in our garden in Brandenburg. It is a nice contrast to the busy city life in Berlin and allows me to escape the day-to-day business which I usually spend at my office desk.

Scientific & Regulatory Expert

PRO-LIANCE GLOBAL SOLUTIONS GmbH

Medical Writer & Clinical Evaluation Consultant

Freelancer

Editor

Cornelsen Verlag

Head of Laboratory

University Hospital

Dr. rer. nat. (Biology)

Clinical Evaluation

Biological Evaluation

Risk Management

PMSR

State of the Art Report

Scientific development, study design, study evaluation and implant testing 

Teaching & training

Languages: German, English