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PRO-LIANCE CORE LEARNING
Post-Market Surveillance for Medical Devices – Practical Implementation under the MDR
From PMS planning and data collection to analysis, reporting and continuous improvement

Duration

4 hours

Format Online

Language English

Challenges Addressed

  • How do you build and maintain a PMS system that is both MDR-compliant and useful in practice?  
  • Which post-market data should be collected, from which sources, and how can you determine what is actually relevant?  
  • How do you systematically analyse PMS data and identify meaningful trends, signals or emerging risks?  
  • How should PMS findings feed into the clinical evaluation, risk management, PMCF and other lifecycle processes?  
  • How do you distinguish between a meaningful signal and normal fluctuations or isolated events?  
  • How can PMS documentation and reporting provide real regulatory value rather than becoming a documentation exercise?  

After the Training, Participants Will Be Able To

  • Understand the key MDR requirements and principles for establishing and maintaining an effective PMS system;  
  • Develop or review PMS plans, data sources and surveillance activities based on the device, its risks and available evidence;  
  • Systematically collect, assess and analyse post-market information and identify relevant signals, trends and emerging risks;  
  • Understand how PMS findings should feed into PSUR, PMCF, clinical evaluation, risk management and CAPA;  
  • Identify common PMS weaknesses and apply practical approaches to make their PMS process more efficient, consistent and audit-ready.  

Agenda

  • PMS under the MDR – regulatory framework and lifecycle perspective  
  • PMS system, PMS plan and PMS documentation  
  • Identification and selection of relevant post-market data sources  
  • Data collection, screening and evaluation  
  • Analysis of PMS data, signals, trends and emerging risks  
  • Link between PMS and risk management  
  • PMS interfaces with clinical evaluation and PMCF  
  • From PMS data to PSUR and other regulatory outputs  
  • When PMS findings trigger further action: CAPA, FSCA, PMCF updates, changes to the clinical evaluation or risk management  
  • Common PMS pitfalls and practical implementation strategies  

 

 
 
 
Duration: 4 hours | Language: English | Modality: online (via Teams)

Practical Application

The Learning will use a concrete medical-device case study to work through the PMS process from planning and data collection to analysis and follow-up actions. 

Participants will have the opportunity to: 

  • assess different post-market data sources for their relevance;  
  • work through examples of PMS data and identify potential signals or trends;  
  • discuss how PMS findings should be translated into actions;  
  • explore typical interfaces between PMS, PMCF, CER, RM and PSUR;  
  • use practical checklists, templates and examples to support implementation in their own organisation.  

Who should attend?

Employees and professionals from Regulatory Affairs, Quality Management, Clinical Affairs, PMS/PMCF and Risk Management, as well as those responsible for establishing, maintaining or reviewing post-market surveillance processes for medical devices. 

Prerequisites

Basic knowledge of medical devices and the MDR, as well as general familiarity with regulatory or quality processes within a medical-device organisation, is recommended. No in-depth prior experience in PMS is required. 

Why is participation worthwhile

This Learning shows you how to turn PMS from a regulatory obligation into a practical lifecycle process that generates meaningful evidence, identifies emerging risks and drives effective action. 

PRICING AND REGISTRATION

Special offer for companies

Special offer for companys registering more than two participants (440.00 €/person excl. VAT) per company!

Early bird fee

Register 8 weeks prior to event and profit from our early bird fee (440.00 €/person excl. VAT)!

Normal price

Standard registration fee: 490.00 € excl. VAT

11 November 2026

Time 9:00-13:00 (CET)
REGISTER

14 December 2026

Time 14:00- 18:00 (CET)
REGISTER

20 January 2027

Time: 9:00-13:00 (CET)
REGISTER

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FAQ

WHO IS THIS TRAINING FOR?

This training is designed for professionals in Regulatory Affairs, Quality Management, Clinical Affairs, PMS/PMCF and Risk Management, as well as anyone responsible for establishing, maintaining or reviewing post-market surveillance processes for medical devices. Basic knowledge of medical devices and the MDR is recommended, but no in-depth prior experience in PMS is required.

You will learn how to establish and maintain an effective PMS system in accordance with the MDR, from PMS planning and data collection to data analysis, reporting and follow-up actions. The training covers how to identify relevant data sources, assess signals and trends, and understand how PMS findings feed into PSUR, PMCF, clinical evaluation, risk management and CAPA.

The training is highly practical and uses a concrete medical-device case study to work through the PMS process step by step. You will assess the relevance of different post-market data sources, analyse examples of PMS data, identify potential signals and trends, and discuss appropriate follow-up actions. Practical checklists, templates and examples will also help you apply the learning within your own organisation and strengthen your PMS process.

ADDITIONAL INFORMATION

  • Registration and event will be managed via Microsoft Teams. Billing and cancellation information will be sent to you via a separate email after registration.
  • Please note that the training will only take place if the minimum number of 4 participants is reached.
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