Officers and regulatory representatives of TBCT Europe
TABET Serge
Primary point of contact for regulating bodies; Ensure that all regulatory documentation is prepared and maintained; Ensure that technical documentation and the EU Declaration of Conformity are drawn up and kept up-to-date; Ensure that every precaution is taken in the case of investigational devices to protect the health and safety of the subject as it relates to the conformity with the general safety and performance requirements apart from the aspects covered by the clinical investigation.