Officers and regulatory representatives of SOAR & PARTNERS
SANTO Anna
a) Compliance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
b) Review and verification of the technical file of the manufacturer to ensure it is complete, accurate, and complies with the regulations.
c) Implementation and maintenance of a system for reporting serious incidents and suspected incidents involving the medical devices they represent.
d) Liaison with regulatory authorities on behalf of the manufacturer and provision of any necessary information or clarifications.