Date: 15 October 2024
Time: 16:00 – 18:00 CET | 10 AM – 12PM EST
Location: Virtual
Price: € 395,- | $ 427.-
Introduction
Post-Market Clinical Follow-up (PMCF) is the process whereby a manufacturer pro-actively collects and evaluates clinical data of their medical devices that are on the market. The PMCF process updates the clinical evaluation. With the implementation of the Medical Device Regulations (MDR), PMCF became mandatory for all devices in the European Union (EU). But also the scope of PMCF activities became much broader. This training takes a deep dive into the PMCF requirements of the MDR. We will discuss the definition and goals of PMCF, various types of PMCF methods, processes and documentation, and how PMCF can be deployed during the life cycle of your device.
Audience
Professionals in the medical device industry, who have a basic understanding of MDR regulatory requirements and who want to learn the PMCF requirements in detail.
Learning Objectives
- Understand the PMCF requirements under the MDR
- Learn about appropriate methodologies for PMCF
- Understand PMCF planning, execution and reporting requirements
- Understand the role of PMCF in the product life cycle.