Post Market Surveillance under MDR & IVDR International Training

Niveau Spécialiste Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 1190€ + TVA View dates and book your training

This one-day intensive course enables manufacturers to learn about the key requirements, concepts and the overall process for post-market surveillance and vigilance under the MDR and IVDR.

BSI’s ‘Post-market Surveillance and Vigilance under the Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Devices Regulation (IVDR)’ one-day training course has been designed to provide manufacturers with the tools to implement an appropriate system for gaining and reviewing experience in the post production phase from the range of devices they manufacture.

Prerequisites

There are no formal prerequisites for this course.

Pedagogical objectives

Understand the key requirements and concepts of the post-market surveillance and vigilance for the MDR and IVDR
Gain sufficient understanding to be able to write your PMS and vigilance procedures
Communicate the impact of these key requirements introduced by the MDR and IVDR to your organization
To obtain essential knowledge to implement a compliant post-market surveillance and vigilance quality management system
To understand how the PMS and vigilance processes integrate into the quality management system

This course is ideal for you if you’re in a quality assurance/quality control/regulatory/patient safety/customer facing role involved in continuous improvement and customer advocacy.
On completion of this training, you’ll be able to:
- Interpret regulatory requirements for post-market surveillance and vigilance under the MDR and IVDR
- Identify how these requirements relate to ISO 13485:2016, ISO 14971:2019 and various European and IMDRF (GHTF) guidance documents
- Create a post-market surveillance plan that includes both proactive and reactive sources of information
- Implement appropriate post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) as per the MDR and IVDR respectively
- Recognize when incidents and adverse event need to be reported to the Competent Authorities and Notified Bodies for both pre and post CE marked devices
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
Course materials including :
- Introduction to the training, detailed programme and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
This guide will give you all the necessary information.
Download our training guide: Post Market Surveillance under MDR & IVDR
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

Nous contacter

Travaillons ensemble pour bâtir l'avenir de votre organisation

Contactez-nous pour découvrir comment nous pouvons vous aider à réussir

Nous contacter