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Practical Post Market Surveillance for Medical Devices

This 4-day course will provide the practical tools needed to execute the Post Market Surveillance Process (PMS) confidently.   Recently, the PMS process has become critical for ensuring the safety, effectiveness, and ongoing quality of medical devices after they’ve been released to the market. This training class provides a comprehensive understanding of PMS, covering topics such as adverse events reporting, trend analysis, and risk assessment.

Upcoming Virtual Courses

Expert Insights

Practical Post Market Surveillance for Medical Devices (Sep 2024)

Sep 23 to Sep 26, 2024

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Overview

In this hands-on training class, you’ll learn essential requirements for collecting, analyzing, reporting, and applying Post-Market data for medical devices. You will learn and apply how to connect the PMS process to your Quality Management System (QMS) and risk management processes. Whether you’re a manufacturer, regulatory professional, or quality specialist, this course equips you with the knowledge needed to implement practical and effective PMS practices.

Objectives

  1. Understand Post Market Surveillance Requirements and differences in regulatory requirements to comply with US FDA, EU MDR/IVDR, MDSAP,  ISO/TR 20416:2020, and ISO 13485
  2. Acquire practical tools, methods, and strategies to implement the post-market surveillance process and systems.
  3. Be able to make risk-based post-market surveillance decisions including corrections and removals

What to expect

  • Learn about all the elements and documentation required for a project.
  • Plan your design project for 510(k) clearance.
  • Reduce time to market through full regulatory comprehension and strategic planning
  • Lower your company’s dependence on consultants by bringing the regulatory expertise in-house

Who Should Attend?

U.S. and global (e.g., European Union, Association of Southeast Asian Nations) quality and regulatory affairs leaders for Medical Device Manufacturers (MDM); MDMs of new device technologies, such as those developing mobile applications.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.