The product was assessed and the ISO-10993 and FDA G#95 memorandum requirements were reviewed by a BridgeMed solutions expert. The tests advised by the labs, according to the research, are off-the-shelf assays that are not personalised to the product.
Bridgemed is a preclinical center of excellence for medical device interventional research, offering cutting-edge equipment and interventional techniques. Our experts are highly trained and experienced, having trained with some of the most prominent doctors and researchers in the world. tavr biocompatibility studies