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Post Market Surveillance (PMS) under the EU Medical Device Regulation (MDR) Training for Practitioners is for those looking to master the PMS requirements under the EU MDR 2017/745
This interactive course is designed to equip quality and regulatory professionals, medical device manufacturers, and post-market teams with the knowledge and tools to meet these rigorous requirements. From understanding the legal framework to developing a compliant PMS Plan, this course covers every essential aspect of PMS under EU MDR.
With real-world examples, practical activities, and scenario-based learning, you’ll gain the skills to confidently implement PMS processes, generate required reports, and stay prepared for audits and inspections. Whether you’re new to PMS or looking to enhance your expertise, this course provides the insights you need to ensure compliance and protect patient safety.
Our blended learning course is a hybrid approach where you first complete eLearning modules on the underlying theory that better prepares you in advance of attending Live Classes with an Instructor that focus on practical application in a real life context.
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 12 credits by completing this course.
Overview of our Post Market Surveillance (PMS) Practitioner
What's covered on our PMS Practitioner Training
Learners first complete interactive eLearning modules to grasp the underlying theory, then attend live, instructor-led workshops emphasizing practical, real-world application.
- What is PMS? – Definition and Purpose
- PMS and Device Classification
- PMS Link to Device Lifecycle
- Importance of PMS in Ensuring Safety and Performance
- Key Articles Related to PMS (Articles 83-86)
- PMS Requirements by Device Classification
- Relationship with ISO 13485 and ISO 14971
Case Study Analyze a scenario where a device’s PMS obligation were not met and the resulting consequences.
- Key Components of a PMS Plan (Article 84)
- Objectives and Strategy
- Data Sources for PMS Activities
- Responsibilities and Resources
- Practical Steps to Create a PMS Plan
Case Study Review of a PMS Plan
- Data Collection and Analysis
- Signal Detection and Trending
- Integration with Vigilance Activities
Case Study Identifying gaps in PMS Data Collection
- Periodic Safety Update Report (PSUR)
- PMS Report
- Integration with Technical Documentation
Case Study Identify the correct reporting requirements for different device classes
Following completion of the eLearning modules where Learners master the theory, an experienced Practitioner will lead practical workshops diving deeper into PMS and practical application covering:
- Workshop #1 PMS Planning & Data Collection
- Workshop #2 Analyzing PMS Documentation for Compliance
- Workshop #3 Post-Market Clinical Follow Up (PMCF)
- Workshop #4 PMS Integration with QMS
- Workshop #5 PMS Audit Readiness (Simulated Audit)
Michelle Keane
On completion of this course, successful Learners will have the practical knowledge and be able to apply the techniques needed to:
- Define Post-Market Surveillance (PMS) and its significance under EU MDR 2017/745.
- Identify PMS requirements for medical device manufacturers.
- Develop and implement a compliant PMS Plan.
- Evaluate and report PMS findings through PSURs and PMSRs.
- Align PMS activities with other MDR processes, including vigilance and risk management.
- Quality Professionals
- Quality Engineers
- Regulatory Professionals
- Internal Auditors
- Lead Auditors
- Management Representatives
- Top Management
Before completing this course, each Learner should have the following prior knowledge:
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 (12).
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 assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for (applies to blended format only)
- Fully attend the Instructor Workshops as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
For the live workshops during a virtual delivery, we utilize Microsoft Teams and SharePoint.
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.
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Frequently Asked Questions
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What Our Learners Are Saying
4.4
Average Rating
13 global ratings
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Very good thank you
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The course really helped me get an overall understanding of the PMS under MDR that I can apply in my current role.
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Excellent course content with the participants interaction supporting each other understand the requirements.
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I thoroughly enjoyed the training course. The blended learning approach with no PowerPoint slides was a refreshing approach. The trainer was very knowledgeable on the topic and very personable. her energy in delivering the course kept us all engaged and elicited contributions from all participants.
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An excellent interactive course with a very knowledgeable instructor.
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