Training Features

Introduction to Risk Management (ISO 14971:2019)

Explore the principles of ISO 14971:2019 and learn how to identify, assess, and control risks in medical device development.
Format

E-Learning

Level

Basic

Trainer

René Schings

Exam

Exam and certificate included

Duration

2 hours
6 modules

Price

€ 345 or equivalent currency

Introduction to Risk Management (ISO 14971:2019)

Risk management is a cornerstone of safe and compliant medical device development. This self paced e learning provides MedTech professionals with a clear and practical introduction to the principles, terminology, and regulatory expectations of ISO 14971:2019. Through structured modules, real world examples, and knowledge checks, participants gain insight into how risk management is applied throughout the entire medical device lifecycle, from initial planning and design to post market activities.

Led by René Schings, this basic level training is designed to build a solid foundation, helping participants understand not only what the standard requires, but also why effective risk management is essential for patient safety, product quality, and regulatory compliance. The training can be completed in approximately 1.5 to 2 hours and fits easily into a busy professional schedule.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
Upon completion of this training, the participant will be able to: 
  • Define the core principles of risk management and its importance in the medical device life cycle. 
  • Identify and explain the requirements of the ISO 14971:2019 standard. 
  • Outline the step-by-step Risk Management Process, from planning to post-production. 
  • Differentiate between key terms such as Harm, Hazard, Hazardous Situation, and Risk. 
  • Apply the hierarchy of risk control measures and understand the concept of overall residual risk. 
  • Participate in a multi-disciplinary risk management team. 
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
  • Duration: Approx. 2 hours.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This training is intended for the following roles and profiles:
  • Quality Engineers
  • Regulatory Affairs Specialists
  • R&D Engineers
  • Design Engineers
  • Manufacturing Personnel
  • and Managers who are new to formal risk management in the medical device industry, or those needing a refresher on ISO 14971:2019. 

Comprehensive Regulatory Expertise

Flexible learning designed for busy professionals seeking regulatory expertise.
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

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

René Schings

René, with over 20 years of management experience in Quality Management, Research & Development, and more, serves as a lead auditor at Qserve, specializing in ISO audits, and brings expertise in building QMS for start-ups, managing complex change projects, and overseeing multi-site, multi-cultural teams, having previously held senior positions in the Medical Device and Consumer Electronics industries.
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