Medical Device Postmarket Surveillance – PMS

- How to maintain an efficient PMS system in compliance with ISO 13485, MDR / IVDR and QSReg

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

ONLINE

During this one day course, you will get a good insight and understanding of the key requirements that shall be fulfilled to establish and maintain a postmarket surveillance system in compliance with EU and US Medical Device regulations.

Course description

The course provides practical guidance on how to implement the requirements on Postmarket Surveillance (PMS) in your quality management system and establish a system for proactive and reactive data collection and subsequent data/trend analysis, to identify potential and existing nonconformities. This course outlines the postmarket surveillance process; from the planning phase to implementation and analysis.

Course outline

  • How to create and update your Postmarket surveillance plan.
  • Analysis and evaluation; trending.
  • Important elements of your quality management system to ensure compliance to PMS regulations.
  • Periodic safety update reports – new PMS reporting requirements under MDR.
  • Relation between PMS, risk management and clinical evaluation.

Learning objectives

To get a thorough understanding of the requirements on Postmarket Surveillance (PMS) in MDR and IVDR as well as FDA’s requirements on PMS. Know how to establish and assess the postmarket aspects of your process for measurement, analysis and improvement, according to ISO 13485:2016. Understand the link between risk management, postmarket surveillance and clinical evaluation; especially postmarket clinical follow-up. Learn about requirements on different stakeholders for regulatory reporting as defined in EU and US regulations.

Who should attend

The course is suitable for persons working with quality and/or regulatory for medical devices who is involved in parts of, or responsible for the postmarket surveillance and vigilance reporting for medical devices.

Prerequisites

  • You should have basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company’s internal quality assurance programs.
  • You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).

#5123

 950

No. persons
Discount:
3 persons or more 15% if registered and invoiced together for the same course.
Date & Time
October 8, 2025
9.00-17.00 CET
IndustryIVD, Medical Device
LanguageEnglish
LevelIntermediate
LocationOnline
RegionEU/US
YOUR INSTRUCTOR(S)​

Anna Sahlholm

Share
CUSTOMIZE IN-HOUSE TRAINING?

Search

Search

Customized In-House training

To tailor the course to your needs, we would like you to take these questions into account when contacting us.

  • What topics do you want to include in the training?
  • Experience and knowledge level in the group? Similar or varied?
  • How many participants do you want to take part in the training?
  • Are there any specific routines that need improvement?
  • Would you like a verification test after the training?
  • Extent of the training, and preferable timeframe?
  • Online or as a on-site course at your location?

Send an Inquiry

We take great care of your contact details. To learn more, read our Privacy Policy