Medical Device Postmarket Surveillance – PMS

Course description

The course provides practical guidance on how to implement the requirements on Postmarket Surveillance (PMS) in your quality management system and establish a system for proactive and reactive data collection and subsequent data/trend analysis, to identify potential and existing nonconformities. This course outlines the postmarket surveillance process; from the planning phase to implementation and analysis.

Course outline

• How to create and update your Postmarket surveillance plan.
• Analysis and evaluation; trending.
• Important elements of your quality management system to ensure compliance to PMS regulations.
• Periodic safety update reports – new PMS reporting requirements under MDR.
• Relation between PMS, risk management and clinical evaluation.

Learning objectives

To get a thorough understanding of the requirements on Postmarket Surveillance (PMS) in MDR and IVDR as well as FDA’s requirements on PMS. Know how to establish and assess the postmarket aspects of your process for measurement, analysis and improvement, according to ISO 13485:2016. Understand the link between risk management, postmarket surveillance and clinical evaluation; especially postmarket clinical follow-up. Learn about requirements on different stakeholders for regulatory reporting as defined in EU and US regulations.