Medical Device Postmarket Surveillance – PMS Course

Struggling to keep your PMS system compliant across EU and US regulations?

This one-day course cuts through the complexity of MDR, IVDR, and QSReg to give you practical, actionable guidance. You’ll gain a clear understanding of the key requirements for establishing and maintaining a robust post market surveillance (PMS) system that meets both EU and US medical device regulations.

Through real-world examples and expert insights, the course walks you through the entire PMS process—from planning and implementation to data collection, trend analysis, and reporting. You’ll learn how to integrate PMS into your quality management system, identify and address nonconformities, and understand how PMS connects with risk management and clinical evaluation.

Learning objectives

• Confidently interpret PMS requirements under EU MDR, IVDR, and US FDA QSReg.
• Design and assess post market processes for measurement, analysis, and improvement in line with ISO 13485:2016.
• Understand how PMS connects with risk management and clinical evaluation, including Post Market Clinical Follow-up (PMCF).
• Identify and fulfil regulatory reporting responsibilities across EU and US markets

Course outline

• PMS Planning 
  Learn how to create and update your PMS plan in alignment with MDR, IVDR, and QSReg requirements.
• Data Analysis & Trending 
  Explore methods for proactive and reactive data collection, trend analysis, and evaluation to identify nonconformities.
• QMS Integration 
  Understand the key elements of your Quality Management System (ISO 13485) that support PMS compliance.
• Regulatory Reporting 
  Get familiar with the new PMS reporting requirements under MDR, including Periodic Safety Update Reports (PSURs).
• Cross-functional Linkages 
  Examine the relationship between PMS, risk management, and clinical evaluation, including Post Market Clinical Follow-up (PMCF).

Target Audience

Who should attend:
This course is ideal for professionals working in quality assurance or regulatory affairs within the Medical Device industry, particularly those involved in post market surveillance and vigilance reporting.

Prerequisites

• You should have completed a basic course in quality systems or possess equivalent internal training.
• You should have worked for at least 6–12 months in the regulated Medical Device or Pharmaceutical industry.

*MDR – EU Medical Device Regulation
*IVDR – EU InVitro Diagnostic Device Regulation
*QSReg – US Medical Device Quality System Regulation 21 CFR 820

#5123