Do you want to develop a simple or a complex medical device, i.e., an implant (class III) that contains a drug with an ancillary action?
We have experts to help with the required biocompatibility and clinical evaluations.
Our expertise in pharmaceutical and medical device development bridges both worlds.
We can define a rational concept, that embraces both the requirements of the conformity assessment procedure and the consultation process with the competent authority for medicinal products. This allows to define subjects to be developed in a modular fashion that may be used synergistically. The modules may also be inserted into the dossiers for markets other than Europe. Our rational concept yields significant cost and time reduction.