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