Location

Productivity and Quality Institute - Alexandria

Objectives

• The course will help you:Understand the key requirements and concepts of the post-market surveillance and vigilance for the MDR and IVDRGain sufficient understanding to be able to write your PMS and vigilance proceduresCommunicate the impact of these key requirements introduced by the MDR and IVDR to your organizationTo obtain essential knowledge to implement a compliant post-market surveillance and vigilance quality management systemTo understand how the PMS and vigilance processes integrate into the quality management system

Outcomes

On completion of this training, you’ll be able to:Interpret regulatory requirements for post-market surveillance and vigilance under the MDR and IVDRCreate a post-market surveillance plan that includes both proactive and reactive sources of informationImplement appropriate post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) as per the MDR and IVDR respectivelyRecognize when incidents and adverse event need to be reported to the Competent Authorities and Notified Bodies for both pre and post CE marked devices

Course Contents

• The Structure of Post Market Surveillance• Egyptian System• Complaints • Medical Device Reports• Corrections and Removals• International Systems• Post Production Information Collection• Critically evaluate the requirements and guidance for post-market surveillance.• Critically evaluate the requirements and guidance and vigilance.• Possess a systematic understanding and critical awareness of the international requirements including legislation, guidance and associated documentation relating to surveillance and vigilance for medical devices.