Development of new medical devices must provide maximal patient safety, efficacy and suitability for the purpose.
Extensive and expensive studies must be carried out before the product can be released to the market.
Despite the scrutiny of regulatory demand and the extensive progress made, many cases have being seen when medical devices fail to perform due to adverse and unforeseen effects.
Biomaterials are being tested in oversimplified conditions, assuming ideal situations, or in poorly controlled animal models. But clinical reality is far from those and there is an urgent need in novel platform for proper assessment of biomaterials.
Our team has established Seqvera Ltd. to provide solutions for these challenges and to support patients safety with better medical devices.
The company is based on the original know-how (several EU and national R&D projects) and strategic partnerships, backed with many years of experience in developments of biomaterials design, processing, evaluation and application as well as within medical device sector.
New medical device regulations (2017/745) enable and in many cases require BEST to be used for biomaterials and medical devices, inclusive of ones containing for example drugs or tissue derivatives.
The European Citizens Initiative C(2015) 3773 "Stop Vivisection" demands from the authorities to implement the "3R" (Reduction, Refinement, Replacement) Directive 2010/63/EC to develop alternative tests instead of use animals.
That is why we do BEST.
We are honored to cooperate and assist you in your research and development activities. Please use feedback form to contact us. We discuss about the proper testing conditions and elaboration of your own BEST protocol.
Make your product the BEST one!
Dr. Michael Gasik, Prof., Dr. Sci., Chairman of the Board
We are pleased to thank our BEST partners for the cooperation!