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
Skills to be acquired
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
Targeted audience
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.
Pedagogical, technical and framing means
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
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
What is included ?
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
