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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
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.
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Course Structure Explained
Detailed Breakdown & Agenda
Attend live, instructor-led workshops emphasizing practical, real-world application.
| Time | Topic |
|---|---|
| #1 | Introduction to the EU MDR 2017/745 and PMS
|
| #2 | Legal and Regulatory Framework for PMS
Practical Workshop Analyze a scenario where a device’s PMS obligation were not met and the resulting consequences. |
| #3 | Developing a PMS Plan
Practical Workshop Review of a PMS Plan |
| #4 | Conducting PMS Activities
Practical Workshop Identifying gaps in PMS Data Collection |
| #5 | PMS Reporting Requirements
Practical Workshop Identify the correct reporting requirements for different device classes |
Course Overview
Post Market Surveillance (PMS) under EU MDR 2017/745
On completion of this course, successful Learners will have the practical knowledge to support their overview of the CAPA Process as defined in ISO13485 and 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
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 ISO14971
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:
- Fully attend the Live Instructor Workshop as 100% attendance is required
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.
Why Choose Comply Guru
About our Post Market Surveillance Training
Learn about the benefits and key features of Comply Guru’s Instructor led Learning.
