Course aim

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.

Course description

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

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

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

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.

How will I learn?

This is an online, interactive on-demand course. 

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.

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.

During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned.

The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

You should have a basic understanding of European Medical Device and In-vitro Diagnostic Regulations (MDR).

Further information

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

Delegates completing the course will be issued an attendance certificate. By taking and passing the optional end-of-course exam, delegates will be issued with a further certificate of achievement.

Modules

• Module 1: Post-market Surveillance (PMS) and its Importance
• Module 2: Post-market Surveillance (PMS) and The Quality Management System (QMS)
• Module 3: Post-market Surveillance (PMS) Plan Contents
• Module 4: Proactive and Reactive Sources of Information
• Post-market Clinical Follow-Up(PMCF) and Post-market Performance Follow-Up(PMPF)
• Module 6: Vigilance and the Reporting Process