Pilot studies are used to analyze possible problem-solving approaches and products regarding feasibility. Risks are identified and chances of success estimated.
The WetLab scenario allows the execution of operation techniques in a clinically oriented setup. Conception, organization and execution will be acquired together with our client and a suitable partner. Furthermore, the WetLab scenario offers the possibility of training for surgeons and clinical staff.
Depending on the requirement of the designated authority or the FDA commission, clinical studies are the preconditionof CE labeling or FDA approvals.
OTM supports you making up all the documents needed and helps you formulating the ethical application.