The Medical Devices Introductory Course 2020

Key Post-Marketing Responsibilities

• Risk Management

• Medical Device Vigilance (incident reporting)

• Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF) and ongoing Clinical Evaluation

• “Field Safety Corrective Action” (FSCA) and “Field Safety Notices”

• Quality Management System – NB Continuous Assessments and Unannounced Audits

• Technical File Maintenance – NB Technical Review sample audits

• National Registration (Notification Listings)

The Organisation for Professionals in Regulatory Affairs

Key Post-Marketing Responsibilities

• Risk Management

• Medical Device Vigilance (incident reporting)

• Post-Market Surveillance (PMS), Post-Market Clinical Follow- up (PMCF) and ongoing Clinical Evaluation MDR A ditional process / documentation requirements: • PMS Plan, • “Field Safety Corrective Action” (FSCA) and “Field Safety Notices” • Summary of Safety & Clinical Performance, • Periodic Safety Update Reports (PSURs), • Registration via and reporting to EUDAMED database • Quality Management System – NB Continuous Assessments and Unannounced Audits • Technical File Maintenance – NB Technical Review sample audits

• National Registration (Notification Listings)