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An Introduction to Post Market Surveillance (PMS) under the EU Medical Device Regulation (MDR) Training is for those looking to understand the PMS requirements under the EU MDR 2017/745 at their own pace, on their own schedule.
This interactive eLearning course is designed to equip quality and regulatory professionals, medical device manufacturers, and post-market teams with the knowledge to understand these rigorous requirements. This course covers every essential aspect of PMS under EU MDR.
Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
This training course recognized by the Regulatory Affairs Professionals Society (RAPS) offering global recognition for successful learners. RAPS members will also be eligible to receive 6 credits by completing this course.
Have 5 or more that need training?
We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.
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Our Methodology
Not all eLearning is the same
Most other providers offer online training that is one-dimensional utilizing either Videos or PowerPoint Presentations. That is not effective training. Our experienced team of subject matter experts, graphical & instructional designers, and training specialists deploy a multi-layered methodology that offers you a New Generation of eLearning.
Course Structure Explained
eLearning Module Breakdown & Timings
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
| Time | Topic |
|---|---|
| 40mins | Module 1: Introduction to the EU MDR 2017/745 and PMS
|
| 90mins | Module 2: Legal and Regulatory Framework for PMS
Case Study Analyze a scenario where a device’s PMS obligation were not met and the resulting consequences. |
| 55mins | Module 3: Developing a PMS Plan
Case Study Review of a PMS Plan |
| 80mins | Module 4: Conducting PMS Activities
Case Study Identifying gaps in PMS Data Collection |
| 55mins | Module 5: PMS Reporting Requirements
Case Study Identify the correct reporting requirements for different device classes |
Our Experts
Meet The People Behind The Course
Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training
Our Instructor
Michelle Keane
Our Graphical & Instructional Designer
Leon Donnellan
Our Training Specialist
Eoin Philip Kelly
Course Overview
Introduction to Post Market Surveillance (PMS)
On completion of this course, successful Learners will have the knowledge to:
- Understand the core PMS requirements under EU MDR 2017/745
- Implement a risk-based PMS system aligned with QMS requirements
- Conduct PMS documentation effectively
- Comply with PSUR and PMS reporting obligations
- Integrate PMS into the regulatory and quality management strategy
- Quality Professionals
- Quality Engineers
- Regulatory Professionals
- Internal Auditors
- Lead Auditors
- Management Representatives
- Top Management
EU MDR 2017/745
- Familiarity with the structure and key provisions of the EU Medical Device Regulation 2017/745.
- Basic knowledge of medical device classification and conformity assessment procedures under EU MDR.
ISO 13485
- Must have experience of working with ISO 13485:2016 or knowledge of ISO 13485:2016
Medical device management systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- The process approach used in quality management.
ISO 14971
- Basic understanding of ISO 14971
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (6).
Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
If you are completing this training virtually, the following applies:
For the live workshops during a virtual delivery, we utilize both Zoom and Microsoft Teams.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Watch and Learn More
About Our Training
Learn about how our Post Market Surveillance under the EU MDR 2017/745 Training is leading the industry for innovation through online learning
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.5
Average Rating
2 global ratings
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This is a great course for anyone trying to get up to speed with the PMS requirements of the EU Medical Device Regulation. It tackles the relevant sections of the regulation and breaks down their application according to device classification.
