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Thomas was a typical child of the 60s and 70s, growing up in a rural environment. He attended a renowned grammar school, a traditional school that had developed from a local Latin school and was first mentioned in documents as early as 1354. Here he learned to appreciate the values of diligence, fairness and justice and what it means to take responsibility. His interest quickly went beyond the school subject matter, and so he sought to explore the various facets of the global world through intensive study of Scientific American and The Economist.
Meanwhile, Florian showed interest in various adventures that country life offered. In the process, he also slipped into different roles from time to time. He set goals for himself and engaged in planning and execution. As a young track and field athlete, he learned to improve performance through continuous training and celebrated small and big successes both as an individual and with the whole team. The ambition has remained until today.
He had always been fascinated by the natural sciences, especially chemistry, mixing ingredients (which he still likes to do in the kitchen). But he was not one for basic research, his research results were supposed to bring direct benefits to people. This desire led him to various roles in the pharmaceutical, biotechnology and medical device industries.
His thirst for adventure brought Florian to the USA during his school years, where he first earned his high school diploma and later spent a practical semester during his biomedical engineering studies. Further parts of his studies took him to Cuba and Switzerland, where he observed the differences from relatively unorganised to highly organised within a few months and was able to gain something from both worlds. Freedom on the one hand and structure on the other inspire Florian in his daily work.
Summer 2010. A café in Münster. It was there that we (the founders of PRO-LIANCE GLOBAL SOLUTIONS) met for the first time. The chemistry was right – not only with the doctor of chemistry Dr Thomas Brzoska, but also with the medical technology engineer (FH) Florian Tolkmitt. This led to our first collaboration shortly afterwards.
After the first project came a second, a third and many more. We have been very successful in collaborative processing of clinical evaluations (Rev. 3 of the MEDDEV 2.7/1 document) Basically, we can say that we have been active for years without receiving even the slightest complaint on our documents from various Notified Bodies.
Florian changed employers, but the cooperation continued and even intensified from 2014 onwards to the point where it was no longer necessary to have only four hands to complete the tasks, but other network partners had to be involved in the projects.
With the publication of the European Medical Devices Regulation (Regulation (EU) 2017/745), it was clear that there would be an increased need for clinical evaluations and related activities, such as collecting clinical data in the context of PMCF studies or other clinical follow-up activities.
We decided to found PRO-LIANCE GLOBAL SOLUTIONS in 2018 with a clear focus on the topic of “Clinical & Co”. We wanted to balance demanding work with private life, attract the best minds and enable self-determined working. Through the existing network, we were able to hire our first employee shortly after the start.
Florian has long been involved as a speaker at various seminar and training providers and has also been giving a lecture at the Lübeck University of Technology on the topic of clinical evaluation since 2019. In addition, he is on the board of the RAPS Deutschland e.V. association, which was founded in 2019, and organises a wide range of networking events on the latest regulatory topics with committed regulatory affairs professionals, which are attended not only by manufacturer representatives, but increasingly also by colleagues from authorities and notified bodies.
Our interdisciplinary team works from the various large and small cities in Germany and, together with our network of experts, also across national and continental borders. We are motivated to help our clients from the medical device industry over the regulatory hurdles. Together we develop concepts for the systematic collection of the necessary clinical data and support the implementation of the activities.
Our regular exchange with manufacturers, auditors, reviewers from Notified Bodies and also other consultants enables us to get to know the most diverse perspectives on the challenges of all those involved, to take these into account in our daily work and to find the right solutions even for tricky issues. Our client base is growing and so is our range of services. And of course our team as well.
A year of renewal, a year of change. PRO-LIANCE’s growth continues steadily. In order to remain a modern, dynamic company and to promote the skills of the individual employees to the maximum, the flat, organisational structure remains in place. Customer centricity is at the forefront and determines the daily actions of the PRO-LIANCE team.