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.
How will I benefit?
The course will help you:
- 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
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.