Overview of the PMS and PMCF requirements under the Medical Device Regulation (MDR)

This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned.

Training Objectives:

• Understand Post Market Surveillance (PMS) & Post Market Clinical Follow-up (PMCF) requirements under the MDR 
• Understand the PMS process (including its subset of PMCF) in the medical device lifecycle 

Training Content:

• Importance of PMS and PMCF under the MDR and their role in the global product lifecycle 
• Overview of possible PMS and PMCF activities  
• Understanding the difference between active and reactive PMS/PMCF 
• Creating compliant PMS and PMCF plans for products or product families 
• Creating compliant PMS/PSUR & PMCF reports 
• Introduction to SSCP (Summary of safety and clinical performance) 
• Use of PMS & PMCF data to support clinical evaluation 
• Introduction to Guidelines related to PMS and PMCF activities 

Training Format:

• Presentation with interactive discussions
• Exercises during the training
• End of training assessment (participants will receive a training certificate)

Who Should Attend:

• Managers and employees working in Quality Assurance or Regulatory Affairs departments of medical device manufacturing companies 
• Managers and employees working in Research and Development departments of medical device manufacturing companies 
• Technical medical device consultants and associates 
• Auditors of medical devices