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.
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.
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
Who should attend?
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.
Prerequisites:
You should have experience or basic knowledge of quality management systems for the medical device industry. We recommend you have a basic awareness of medical regulations, medical device development or quality assurance.
What will I learn?
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
Practical information:
- It's a 1-day course
- The training and materials will be provided in English
- Lunch and drinks are included
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.se@bsigroup.com or 0031-(0)20 346 0780.
