Training Features

GCP & ISO 14155: Conducting Clinical Investigations and PMCF Under the EU MDR

Join our virtual training to master GCP and ISO 14155, and learn how to effectively conduct clinical investigations and PMCF studies under the EU MDR.
Format

Virtual Training

Level

Basic

Date

8 April 2026

Time

14:00 - 18:00 CET

Duration

4 hours

Trainer

Daphne Smit-van den Hof

Certificate

Certificate included

Price

€ 595 or equivalent currency

About the Good Clinical Practice (GCP) and ISO 14155 training

High-quality clinical research, accurate documentation, and compliance with regulatory standards are essential for obtaining market approval for new medical technologies. Upon completing the Good Clinical Practice (GCP) and ISO 14155 training, you will be equipped to design and conduct patient-focused clinical investigations in accordance with both national and international regulatory requirements.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Good Clinical Practice (GCP) for medical devices, as outlined in ISO 14155, is essential for ensuring the ethical, scientific, and regulatory integrity of clinical investigations. Under the Medical Device Regulation (MDR) 2017/745, clinical investigations play a critical role in demonstrating the safety and performance of medical devices, while Post-Market Clinical Follow-up (PMCF) ensures continued compliance after market entry. 

Led by Daphne Smit-van den Hof, this training is helps professionals understand the practical implementation of ISO 14155 and MDR requirements for clinical investigations and PMCF. This course provides insights into study design, data collection, regulatory submissions, and compliance with Notified Body expectations. Participants will receive a certificate upon completion, confirming their understanding of GCP principles and MDR compliance in clinical research and post-market activities.
Key Learning Objectives
  • Understand the principles of GCP and ISO 14155 for medical device clinical investigations 
  • Learn the MDR requirements for clinical investigations and PMCF compliance 
  • Gain knowledge of ethical considerations, informed consent, and patient protection 
  • Develop skills in designing, executing, and monitoring clinical investigations 
  • Understand how PMCF activities contribute to ongoing MDR compliance 
  • Learn how to generate and integrate clinical data into regulatory documentation 
  • Identify common challenges and best practices in clinical research under MDR.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training sessions
  • 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 8 April 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If the April training date is not suitable, additional sessions will be held on 4 February, 8 July, and 7 October. For more information visit the registration pages.
Who Should Attend?
  • Clinical Affairs and Clinical Research professionals 
  • Regulatory Affairs specialists involved in clinical investigations and PMCF 
  • Quality Assurance (QA) professionals ensuring compliance with GCP and MDR 
  • Medical device manufacturers conducting clinical investigations under MDR 
  • Clinical trial investigators and study coordinators 
  • Anyone responsible for clinical data collection, monitoring, and reporting.
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
  • Regulatory Framework for Clinical Investigations & PMCF: ISO 14155, EU MDR (Articles 62–82), and differences between pre-market and PMCF studies. 
  • Ethical & Regulatory Compliance: GCP principles, Ethics Committees, Competent Authorities, and informed consent. 
  • Design & Execution of Clinical Investigations: Study planning, protocol, approvals, investigator roles, site selection, and data handling. 
  • Post-Market Clinical Follow-up (PMCF) Requirements: PMCF activities, alignment with Clinical Evaluation Reports, and MDR integration. 
  • Risk-Based Monitoring & Data Integrity: Monitoring strategies, data integrity, audit readiness, and addressing deficiencies. 
  • Integration of Clinical Data into Technical Documentation: Linking data to technical files, preparing study reports, and ongoing clinical evidence. 
  • Challenges & Best Practices: Lessons from audits, case studies, regulatory feedback, and integrating PMCF strategies.
Meet the Trainer

Daphne Smit-van den Hof

Daphne is a seasoned Senior Clinical Project Manager based in The Netherlands, bringing 18 years of clinical trial experience across hospitals and CRO environments, known for her practical leadership in full service project management, her strong background in interventional studies across multiple pathology areas, and her clear, solution driven communication style that keeps complex Pharma, Medical Device, and IVD trials running smoothly and in full compliance.