DER-2000018

Post Market Surveillance under EU MDR 2017/745

Online TrainingIntermediate

•Define Post-Market Surveillance (PMS) and explain its significance in the medical device industry

•Learn about the elements and components of an effective PMS system
•Understand the role of a PMS plan in guiding PMS activities
•Gain insights into how PMS reports contribute to regulatory compliance
•Describe the significance of trend reporting and the analysis of PMS data in improving device safety
•Define Post-Market Clinical Follow-up (PMCF) and its role in PMS
•Describe the role of a Summary of Safety and Clinical Performance (SSCP) in providing transparency and information to health care professionals and users

The Post Market Surveillance course is designed for employees of a medical device manufacturer, specifically for those working in quality assurance or regulatory affairs, and service providers to the industry.

The Post Market Surveillance course is part of a modular concept under the MDR Expert Certification Program. The course helps you understand the new and key requirements and expectations for PMS and vigilance in the Medical Device Regualtion (MDR EU 2017/745). We also talk about how to plan and implement a PMS System, reporting and vigilance systems and linking it with a existing Quality Management System (QMS).

•Introduction to Post Market Surveillance

•PMS in the medical device industry
•Articles of Medical Device Regulation for PMS
•Responsibilities for PMS
•The PMS System
•PMS Plan
•PMS Reports
•Post Market Surveillance Report (PMSR)
•Periodic Safety Update Report (PSUR)
•Post Market Clinical Follow-Up
•Summary of Safety and Clinical Follow-Up (SSCP)
•Vigilance

The course employs a variety of training tools such as content-embedded assessment, animations, and other interactive exercises to enhance instructional delivery. Easily accessible via your preferred choice of device, the course allows you to log in and learn whenever, wherever.

System requirements

Supported browsers include:

  • Chrome
  • Safari
  • Internet Explorer
  • Firefox

Additional requires include:

  • A high speed internet connection will provide best results.
  • An email address is required to register for courses.
  • Microsoft Media Player or equivalent is needed to play audio and video files.
  • Flash Player is used for content and interactive learning. If necessary download and install Flash Player to ensure proper operation of course content.

What is included with the course?

Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course.

Can I pause the course and log in to it anytime?

Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 270 days).

Are there any quizzes in the middle of the course?

Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.

Can I get a refund if I cancel my enrollment?

Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.

What happens if I don’t finish the course within the access period?

The standard access period is 270 days to allow sufficient time to complete your course.

If you have questions, or require assistance, you may reach us at [please add here your local linked email address]

To learn more about TÜV SÜD, please click here [link the word "here" with your local website].

Net Price (excl. VAT)
£ 199.00