How to implement a successful Post-Market Surveillance process
Two-day practical course
Regulation (EU) 2017/745 (MDR) requires a Post-Market Surveillance (PMS) system. As a manufacturer, you must systematically and proactively collect information on the experience gained with your products.
In this interactive seminar, you will learn how to demonstrate the safety and clinical performance of your products throughout the entire life cycle.
- Content
- Regulatory fundamentals
- Terms and definitions
- Successful implementation of a Post-Market Surveillance system
- MDR requirements for PMS
- PMS Plan
- PMS Report and PSUR (Periodic Safety Update Report)
- Vigilance
- Post-Market Clinical Follow-up (PMCF)
- Clinical follow-up
- PMCF study
- Relationship between PMS and PMCF
- Integration into the Technical Documentation
- Interfaces with the Summary of Safety and Clinical Performance (SSCP)
- Involvement of Notified Bodies and Competent Authorities
- Your Benefits
- You will learn the regulatory requirements for Post-Market Surveillance.
- You will receive practice-oriented solutions for your company.
- You will learn how to independently create a PMS Plan and collect and generate data going forward.
- You will be able to generate and document the required evidence of conformity.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostics (IVDs)
- Regulatory Affairs Managers
- Quality Managers
- Authors of Technical Documentation
- PRRC (Person Responsible for Regulatory Compliance)
- Marketing
- Service providers
