Training Features

PMCF Surveys: Gathering Clinical Evidence for Medical Devices

Develop an understanding of the clinical data necessary to support CE marking for your device under the MDR requirements.
Format

Virtual Training

Level

Basic

Date

10 July 2026

Time

13:00 - 17:00 CET

Duration

4 hours

Trainer

Jorn van Binsbergen

Certificate

Certificate included

Price

€ 595 or equivalent currency

PMCF Surveys Training: Ensuring Compliance with EU MDR/IVDR Requirements

PMCF surveys are a valuable method for collecting clinical data required as part of Post-Market Clinical Follow-up (PMCF) activities. They offer an efficient way to gather real-world evidence on the safety and performance of medical devices, often at significantly lower cost compared to clinical investigations.

This training provides a comprehensive overview of when and why surveys are an effective PMCF tool, how to determine their suitability for specific devices, and how to develop a robust PMCF survey plan. Participants will also learn to formulate the right questions to ensure the collection of high-quality, meaningful data.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The Medical Device Regulation (MDR) mandates the collection of clinical evidence to demonstrate the safety and clinical performance of medical devices. Clinical data, obtained through clinical evaluations and, when necessary, clinical investigations, is essential for obtaining and maintaining CE marking. For most devices, the collection of clinical data must continue post-market to ensure ongoing patient safety. The applicable regulations, guidance documents, and standards are comprehensive and require careful interpretation, depending on the specific type and risk classification of the device.

Led by Jorn van Binsbergen, this training provides a comprehensive and practical overview of how to design and conduct PMCF surveys in line with EU MDR requirements. Participants will gain a clear understanding of the regulatory expectations for Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF), and how surveys can serve as an effective tool in this process. By the end of the training, attendees will be equipped with the knowledge and tools to implement high-quality PMCF surveys tailored to their specific devices and regulatory needs.
Key Learning Objectives
  • Understand MDR requirements for PMS and PMCF, and how to implement effective PMCF surveys
  • Learn how to select appropriate tools, define safety and performance endpoints, and develop a compliant PMCF Survey Plan
  • Master sample size calculations, statistical principles, and survey questionnaire design to ensure quality data collection
  • Gain skills in programming surveys, managing timelines, and effectively reporting results
  • Understand Notified Body expectations and align your PMCF activities for compliance
  • Learn best practices for designing survey questionnaires that ask the right questions, ensuring the collection of relevant and high-quality data.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in one session, lasting 4 hours, providing a focused and efficient learning experience. The sessions will take place on 10 July 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 6 Februari 2026. More information can be found on the registration pages.
Who Should Attend?
  • Regulatory Affairs professionals involved in EU MDR/IVDR compliance
  • Clinical Affairs specialists responsible for post-market clinical activities
  • Post-Market Surveillance (PMS) teams managing ongoing device monitoring
  • Quality Managers overseeing QMS and regulatory integration
  • Medical device manufacturers seeking cost-effective methods to collect clinical evidence
  • Anyone involved in planning, designing, or executing PMCF activities
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Overview of MDR requirements for Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
  • Available tools and methodologies for conducting PMCF activities
  • Development of a compliant and effective PMCF Survey Plan
  • Defining safety and performance endpoints for meaningful data collection
  • Determining appropriate sample sizes and applying basic statistical principles
  • Designing clear and targeted survey questionnaires
  • Technical considerations for programming surveys and collecting reliable data
  • Planning realistic timelines for survey execution and data analysis
  • Best practices for reporting PMCF survey results
  • Insights into Notified Body expectations and common feedback on PMCF surveys

Flexible Online PMCF Surveys Training Designed for Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with hands-on industry experience, gaining practical insights and a clear understanding of how to design and implement effective PMCF surveys in compliance with EU MDR requirements.

Expert-Led PMCF Surveys Training for Practical Compliance

Meet the Trainer

Jorn van Binsbergen

Jorn van Binsbergen is a clinical writer at Qserve Group, based in the Netherlands, contributing his expertise in clinical evaluations, regulatory affairs, and scientific writing to support the development and post-market assessment of medical devices.