This 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.
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
Please note: The eLearning training lasts approximately 4-5 hours and is in English.
Benefits of On-Demand for the individual
Convenient - courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection
Learning pace - You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue
Information retention - During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned
High-quality materials - Developed by top subject matter experts, course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning
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.
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
What is included?
On successful completion of the training, participants will receive an internationally recognized certificate.
Prerequisites
Delegates should have a basic understanding of European Medical Device and In-vitro Diagnostic Regulations (MDR).
Delegate assessment
Participants:
- Have 60 consecutive minutes for ending the exam
- Will not be able to pause or save their work.
- Have the opportunity to review all answers before clicking complete, as long as it’s within allocated time.
- Have 30 days to successfully complete the examination and allowed one (1) re-take if necessary.
- The examination is 'open-book' which means participants are permitted to access reference materials during the exam.
- The pass mark is 70% and delegates can see their score on completion.
