Why to do BEST?
All medical devices, based on biomaterials, combined medicinal products, and tissue derivatives, must demonstrate regulative conformity (EU MDR 2017/745). The conformity assessment of a biomaterial depends on its clinical application, conditions and requirements.
BEST is implemented on special equipment and with algorithms for evaluation in a way to respond as much as possible to the clinical targets.
It is vitally important to reduce risk/benefit ratio, improve patient safety and decreasing the lead time and costs at R&D and production.
BEST excels existing, often oversimplified, protocols and provides tangible outcomes promoting translation from bench to bedside.
Reduction, refinement and replacement (the "3R") of animal testing is one of the modern development in medical technology (2010/63/EC).
BEST targets on full deployment of alternative methods ("not tested on animals").
BEST applications span many medical and clinical applications with a great variety of the functionality, optimization and risk assessment actions:
Spinal / IVD