The Post Market Surveillance is a procedure referred to the manufacturer and it is essential in order to place the device on the market. The PMS & PSUR template, guidelines the manufacturer in order to develop a successful PMS plan and report. Additionally, for the manufacturers of class IIa, IIb and III, this template illustrates guidelines to develop the Periodic Safety Update Report (PSUR). This template includes all the requirements of the procedures of PMS and PSUR by giving descriptions and any necessary information required from the regulation MDR 2017/745.
Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.
Our consultants are available, should you need further assistance in completing the documentation.