TRAINING
IVDR PMS and PMPF and how to implement the requirements
The aim for PMS & PMPF training course is to understand the key concepts, what are the requirements and expectations in the new landscape of the IVDR?
In the post market surveillance part you learn about PMS requirements according to the IVDR and everything related or associated with that. You will also learn about Post Market Performance Follow-up (PMPF). Qserve can cover the product development process if a company is interested, from concept to launch and then on market and post market surveillance as this training course covers both topics. Besides this you will learn about the basics of vigilance reporting and the responsibilities for PMS/PMPF activities.
Program Overview
Duration: 2 hours (virtual or customized in-house, to be determined in consultation)
- Post market surveillance versus Market surveillance
- Post market surveillance (PMS)
- Post Market Performance Follow-up (PMCF)
- Vigilance
- Periodic Safety Update Report (PSUR)
- Responsibilities
- Final remarks
- Q&A
Who should attend?
- Regulatory Affairs Managers, Quality Managers and/or Directors
- Clinical Affairs
- R&D, Product Development, Manufacturer, Operations and Marketing Managers
- International registration department
There is no prerequisite for this course. but participants will benefit from a basic knowledge of the In Vitro Diagnotics Regulation in Europe.
Costs
- Price on application for customized trainings, tailored workshops, on-location training, train-the-trainer formats or multiple training courses
Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.