How to implement a successful Post-Market Surveillance Process
Regulation (EU) 2017/745 (MDR) requires a post-market surveillance (PMS) system. Manufacturers must therefore systematically and actively collect information on experiences with their products.
In this interactive seminar, you will learn how to demonstrate the safety and clinical effectiveness of products throughout their entire lifecycle.
- Content
- Regulatory Framework
- Terms and Definitions
- Successful Implementation of a Post-Market Surveillance System
- Requirements of Regulation (EU) 2017/745 for the PMS
- PMS Plan
- PMS Report and PSUR
- Vigilance
- Post-Market Clinical Follow-up
- Clinical follow-up
- PMCF study
- Context of PMS and PMCF
- Integration into the technical documentation
- Interfaces with the summary report on safety and clinical performance
- Involvement of Notified Bodies and regulatory authorities
- Your Benefits
- You will learn about the regulatory requirements for post-market surveillance.
- You will receive practical solutions for your company.
- You will learn how to independently create a plan and collect and generate data in the future.
- You will be able to generate and document the required evidence of compliance.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Regulatory Affairs Managers
- Quality Managers
- Technical Documentation Specialists
- PRRC (Person Responsible for Regulatory Compliance)
- Marketing
- Service Providers
