Post Market Surveillance (PMS) under EU MDR 2017/745

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.

Why Choose Comply Guru?
Highly Interactive, Engaging Experience
Accelerated 'Learn By Doing' Methodology
Delivered by Experienced Practitioners with Proven Expertise
Practical Exercises & Collaborative Learning
Tailored to your Organization
Course Snapshot
 
Approved By
Comply Guru
Duration
16hrs
Teaching Format
Virtual or In-Person Learning
Language (s)
English
Price
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Upcoming Dates
No public dates are available in this region. Using the buttons below, you may request a quote for in-company training, or you may submit your interest to be notified once public dates are announced.
Why Choose Comply Guru?
Highly Interactive, Engaging Experience
Accelerated 'Learn By Doing' Methodology
Delivered by Experienced Practitioners with Proven Expertise
Practical Exercises & Collaborative Learning
Tailored to your Organization

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

  • What is PMS? – Definition and Purpose
  • PMS and Device Classification
  • PMS Link to Device Lifecycle
  • Importance of PMS in Ensuring Safety and Performance
#2

Legal and Regulatory Framework for PMS

  • Key Articles Related to PMS (Articles 83-86)
  • PMS Requirements by Device Classification
  • Relationship with ISO13485 and ISO14971

Practical Workshop Analyze a scenario where a device’s PMS obligation were not met and the resulting consequences.

#3

Developing a PMS Plan

  • 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

Practical Workshop Review of a PMS Plan

#4

Conducting PMS Activities

  • Data Collection and Analysis
  • Signal Detection and Trending
  • Integration with Vigilance Activities

Practical Workshop Identifying gaps in PMS Data Collection

#5

PMS Reporting Requirements

  • Periodic Safety Update Report (PSUR)
  • PMS Report
  • Integration with Technical Documentation

Practical Workshop Identify the correct reporting requirements for different device classes

Course Overview

Post Market Surveillance (PMS) under EU MDR 2017/745

What Will I Learn?

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:

  1. Define Post-Market Surveillance (PMS) and its significance under EU MDR 2017/745.
  2. Identify PMS requirements for medical device manufacturers.
  3. Develop and implement a compliant PMS Plan.
  4. Evaluate and report PMS findings through PSURs and PMSRs.
  5. Align PMS activities with other MDR processes, including vigilance and risk management.
Who Should Attend?
  • Quality Professionals
  • Quality Engineers
  • Regulatory Professionals
  • Internal Auditors
  • Lead Auditors
  • Management Representatives
  • Top Management
What Are The Entry Requirements?

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
Will I Get A Certificate?

Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.

How Will I Be Assessed?

In order to successfully complete this course, each Learner will need to:

  • Fully attend the Live Instructor Workshop as 100% attendance is required
What Are The Technology Requirements?

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.

About our Post Market Surveillance Training

Learn about the benefits and key features of Comply Guru’s Instructor led Learning.

 
Why Choose Instructor led Learning
CQI & IRCA Approved Training Provider

CQI & IRCA Approved Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020