Gruppo SASI offer service "TechFile-Manager"

Gruppo SASI's Technical File management solution for medical devices is built to align with EU Regulations 2017/745 and 2017/746, which define the technical documentation, post-market surveillance documentation and EU Declaration of Conformity requirements in their respective annexes. Facing the growing volume of mandatory documentation, the company offers an organizational model supported by a dedicated software tool comparable to the eCTD document-management systems used in the pharmaceutical sector.