Post Market Surveillance under EU MDR 2017/745 E-Learning
•Define Post-Market Surveillance (PMS) and explain its significance in the medical device industry
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.
TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Academy UK offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Academy do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us.
System requirements
Supported browsers include:
- Chrome
- Safari
- Internet Explorer
- Firefox
Additional requirements 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 365 days).
Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between the 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 before activation.
What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.
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