About Us
We are a consultancy based in central Germany. After each of us has been working for service providers and as freelance consultants in regulatory and clinical affairs, we have joined forces to start our business with the focus on clinical evaluation. We believe that we can deliver the best quality to our clients when we concentrate on one single thing and put all our efforts into doing it with expert knowledge and passion.
Vision
To provide outstanding and unsurpassed services of clinical evaluation and regulatory affairs for our clients, and create a brand trusted by medical device manufactures, notified bodies and competent authorities.
Mission
With the upcoming Regulation (EU) 2017/745 medical device manufacturers are targeted with higher expectations on their clinical data. As a service provider focused on Clinical Evaluation, we aim to be world leader at finding efficient solutions for our clients and enable the medical device industry as well as regulatory authorities to ensure patients with access to safe and high-quality medical devices.
Who we are
We are a high quality international provider of outsourced services to the medical device industry, specialized around clinical evaluation and post-market clinical data management.
Why us?
We are the only service provider highly focused and we pay great attention to the quality of services offered to our clients.
How we work
We are a team of experienced and dedicated scientists, medical and regulatory affairs experts which work together as a cohesive force to compile state-of-the-art and regulatory compliant clinical evaluation reports. We have an excellent understanding of the regulatory requirements and regularly exchange with experts in the field. Our diverse team of qualified authors and evaluators has a broad experience in various areas of the medical device industry and pharmaceuticals. Together we have been involved in more than 200 Clinical Evaluation Reports ranging from class I single use devices over active class IIa and IIb devices, to class III implants and combination products. In addition to our clinical evaluation expertise we have worked in Regulatory Affairs including Risk Management, Quality Management and supported Clinical Investigations. Our Expertise: Orthopeadic implants, Single use devices, Radiology devices, Life-support systems, Substance based products, Drug delivery devices, and many more. Until now, all clinical evaluation reports that have been submitted to notified bodies have been accepted.
Founders team
Florian Tolkmitt
Florian Tolkmitt holds a degree in Biomedical Engineering and completed his studies in Germany, USA, Cuba and Switzerland. After developing single use medical devices and implants, he build up a regulatory affairs and clinical evaluation team for a service provider. Before starting to be a freelance consultant, he worked as Head of Regulatory Affairs for a medical device manufacturer. As a freelancer, Mr. Tolkmitt has build a network of Clinical Evaluation authors and served medical device manufacturers in Clinical & Regulatory Affairs. He has spoken at conferences, provided training and published articles in journals, books and blogs about Clinical Evaluation as a service. With close to 15 years of experience in the medical device industry and with clinical evaluations, Mr. Tolkmitt is responsible for Clinical Evaluation as a Service and building excellent solutions for our customers.
Dr. Thomas Brzoska
Dr. Thomas Brzoska holds a PhD in Chemistry and has done 15 years of work in immunology, cell biology, molecular biology and genetics, resulting in >40 publications, several book chapters as well as several international patents. Dr. Brzoska has also received training as Project Manager (Washington University) and has been responsible for the full development portfolio of a mid-sized German pharmaceuticals and medical device company for several years. He has worked on development and documentation of medical devices since 2007 and as a freelance consultant for the pharmaceutical and medical device industry since 2010. Dr. Brzoska has written and devised more than 100 CERs and biological safety evaluations and participated in different responsible roles in the conception, conduct and evaluation of a number of clinical trials. Dr. Brzoska is responsible for operations, training and is lead CER author.
