PMS PSUR PMCF Gap Assessment
This document aims through infographics and examples to give guidelines to the manufacturer to understand and familiarise his obligations according to PMS, PSUR and PMCF.
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The Post Market Surveillance (PMS) is a post phase process which is accomplished by the manufacturer. If the device is classified as Class IIa, IIb or III, then this process includes a Periodic Safety Update Report (PSUR). Also, the PMS includes the Post Market Clinical Follow Up (PMCF) process which is a continuous process to update clinical evaluation. All these three processes are illustrated in this document focusing on their requirements. This document aims through infographics and examples to give guidelines to the manufacturer to understand and familiarise with his obligations according to these three processes.
Our templates are developed with consultants who have over 20 years of 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.