Deep Dive: Post-Market Surveillance

Categories: Deep Dive, EU, FDA, MDR, US
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About Course

We are currently revising this course. The updated version is expected in December 2024.

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A Deep Dive into Post-Market Surveillance under the EU MDR 2017/745 and US FDA requirements.

Post-Market Surveillance is a universally required aspect of medical device regulations. This ensures device safety and performance across the entire lifetime. We will learn about the key priciples and best practices for establishing and performing PMS activities. We will also focus on regional specific requirements and expectations of various regulatory authorities, including EU Notified Bodies and the US FDA.

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What Will You Learn?

  • Understand the regulatory requirements for Post-Market Surveillance (PMS) under EU MDR 2017/745 and US FDA regulations, including key differences and similarities.
  • Develop comprehensive PMS plans for both EU and US markets, integrating them with Quality Management Systems (QMS) and risk management activities.
  • Collect, analyze, and manage PMS data from multiple sources to identify safety signals and trends, and effectively report findings to regulatory authorities.
  • Implement Post-Market Clinical Follow-Up (PMCF) and post-approval study requirements to maintain compliance and generate clinical evidence.
  • Prepare for regulatory audits and inspections, and apply best practices to build and maintain a robust PMS system that ensures ongoing device safety and performance.

Course Content

Introduction and Background
Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.

  • Welcome!
  • Instructor Tips
  • Scope of the course

Introduction to Post-Market Surveillance (PMS)

PMS Requirements Under EU MDR 2017/745

PMS Requirements Under US FDA Regulations

Developing a Post-Market Surveillance Plan

Collecting and Managing PMS Data

Reporting PMS Findings and Vigilance

Post-Market Clinical Follow-Up (PMCF) and Post-Approval Studies

Risk Management and Corrective Actions in PMS

PMS Audits and Inspections

Case Studies and Best Practices

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