Training Features

Risk Management for Medical Devices: Meeting ISO 14971, MDR & IVDR Standards

Ensure your medical device risk management strategy is audit-ready. This training equips you with the tools to align with ISO 14971 and comply with MDR and IVDR standards.
Format

Virtual Training

Level

Basic/Intermediate

Date

5 and 7 August 2026

Time

09:00 - 17:00 CET

Duration

2 x 8 hours

Trainer

Robert Paassen

Certificate

Certificate included

Price

€ 1495 or equivalent currency

Usability Engineering in Compliance with IEC 62366 for Medical Devices

Risk management is a critical aspect of the medical device lifecycle, ensuring that risks associated with the device are identified, assessed, mitigated, and controlled. ISO 14971 provides the international standard for risk management, and both the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) require manufacturers to implement a robust risk management process throughout the development, manufacturing, and post-market phases. 

This training is designed to help professionals understand the requirements of ISO 14971 and how to apply them in the context of MDR and IVDR compliance. 
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Risk management is an essential part of the medical device lifecycle, aimed at systematically identifying, evaluating, mitigating, and controlling risks to ensure patient and user safety. ISO 14971 serves as the internationally recognized standard for risk management, and its principles are embedded in the requirements of the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). This training provides a comprehensive introduction to building and maintaining a compliant risk management system across all phases of the device lifecycle, from development to post-market surveillance.

Participants will learn to effectively assess and manage risks, ensuring their medical devices meet regulatory requirements and deliver safe and effective products to the market. Upon completion, attendees will have the skills needed to implement and manage risk management processes for medical devices and in-vitro diagnostics in compliance with ISO 14971, MDR, and IVDR. 
Key Learning Objectives
  • Understand the usability engineering process as defined in IEC 62366
  • Learn how to integrate usability engineering into medical device development
  • Identify and mitigate use-related risks in compliance with ISO 14971
  • Develop effective usability test plans and conduct human factors evaluation
  • Understand regulatory expectations for usability under MDR, IVDR, and FDA
  • Learn how to document usability engineering activities for compliance
  • Gain insights into post-market usability monitoring and continuous improvement.
What is included in this live virtual training?
  • Direct access to an expert trainers
  • 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 over two sessions, each lasting 8 hours, providing a focused and efficient learning experience. The sessions will take place on 5 and 7 August 2026.

If the August training date is not suitable, an additional session will be held on 4 and 6 March 2026. More information.
Who Should Attend?
  • Regulatory Affairs professionals responsible for ensuring risk management compliance with ISO 14971, MDR, and IVDR
  • Quality Assurance and Quality Control professionals involved in managing risk assessments and controls
  • Risk Management teams or personnel responsible for identifying and mitigating risks during product development and lifecycle
  • Design and development engineers responsible for integrating risk management into product design
  • Manufacturing engineers responsible for identifying and mitigating risks in the manufacturing of medical devices
  • Post-market surveillance and vigilance teams who monitor and manage product risks post-launch
  • Senior management overseeing risk management processes and ensuring regulatory compliance
  • Internal auditors responsible for evaluating risk management processes and documentation
  • Any professional involved in risk assessment, control, and compliance for medical devices or IVDs
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 Risk Management in Medical Device
  • Understand the importance of risk management throughout the medical device lifecycle, including its role in ensuring product safety and regulatory compliance with ISO 14971, MDR 2017/745, and IVDR 2017/746.
  • ISO 14971:2019 - Risk Management Standard
  • Gain a comprehensive understanding of ISO 14971, including its key principles, risk management process steps, documentation requirements, and its alignment with MDR and IVDR regulatory frameworks.
  • Risk Management Requirements under MDR & IVDR
  • Learn how to fulfill specific risk management obligations under MDR 2017/745 and IVDR 2017/746, integrate risk management with quality management system processes, compile compliant risk management files, and apply risk management principles within post-market surveillance activities.
  • Risk Assessment and Evaluation
  • Understand methods for identifying and assessing risks, such as hazard analysis, FMEA, and fault tree analysis, and learn how to determine acceptable risk, evaluate residual risks, and conduct a risk-benefit analysis.
  • Risk Control and Mitigation Strategies
  • Learn how to implement risk control options, including elimination, substitution, engineering controls, and personal protective equipment, develop effective risk control measures, and document and verify risk control activities.
  • Risk Management in the Post-Market Phase
  • Understand how to manage risk throughout the product lifecycle, including post-market surveillance, risk management updates, and vigilance reporting obligations after product release.
  • Practical Examples and Case Studies
  • Explore real-world examples and case studies of risk management in medical device development, focusing on risk assessments, control measures, and ensuring regulatory compliance.

Flexible Online Training Designed for MedTech 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 practical industry experience and gain clear, actionable insights into applying risk management in compliance with ISO 14971, ensuring your medical devices meet the regulatory expectations of the MDR and IVDR.

Expert-Led Risk Management Training for Practical Compliance

Meet the Trainer

Robert Paassen

Robert Paassen is a Regulatory Affairs & Quality Assurance consultant specializing in EU MDR, serving as a Startup Lead, with expertise in clinical evaluations, quality management system remediation, CAPA management, risk management, and supporting audits.