Risk Management and Risk Analysis for Medical Devices as per ISO 14971:2019
Assess Risks for Medical Devices in Compliance with Standards and Document Results Correctly
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This course is certified by Exemplar Global.
Master Risk Management with Our 2-Day Training Course on ISO 14971:2019 for Medical Devices
Ensure the safety and compliance of your medical devices by mastering risk management and risk analysis as per ISO 14971:2019. Our comprehensive 2-day training course is designed to equip you with the knowledge and skills to implement effective risk management systems in your organization. The training covers all the normative references, general requirements for risk management systems, risk analysis, risk evaluation, and risk control.
As a participant in this course, you will:
- Gain Important Know-How: Fulfill the obligation to introduce a risk management system for medical devices.
- Conduct Standard-Compliant Risk Analyses: Carry out risk analyses that comply with ISO 14971.
- Implement ISO 14971: Successfully implement ISO 14971 in your company.
Join us for this essential 2-day training course to enhance your understanding of risk management and ensure your organization meets the highest standards of safety and compliance. Enroll today and take the first step towards mastering risk management for medical devices!
Course Testimonial: "The course was interactive, education, at the right pace. Overall wonderful learning experience."
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This course is ideal for professionals involved in preparing risk analysis, including:
- Product and Process Developers
- Medical Device Manufacturers and Their Suppliers
- Quality Management and Regulatory Affairs Professionals
- QM Officers
- Safety Officers for Medical Devices
- Consultants and Service Providers
Day 1: Overview of the requirements for ISO 14971 and how to use them
- Applicable standards and their application
- EN ISO 14971:2019+A11:2021
- Definitions
- Risk analysis
- Risk assessment
- Risk control
- Assessment of the overall residual risk
- Downstream phases and the impact of the risk analysis on the QM system
- Risk management report and risk management acts
Day 2: Practice-oriented workshop
- Implementation-oriented workshop
- Practical implementation of the risk analysis
- Creating a risk management plan
- Practical implementation of the standards
- Creating a risk management plan
- Methods of risk analysis
- Carrying out a risk analysis
Functioning risk management is crucial in medical technology. Both ISO 13485 and the Medical Device Regulation (MDR) emphasize the importance of sound risk management. A risk management system is a key legal requirement for all medical device manufacturers worldwide. Systematic risk management in accordance with ISO 14971 helps fulfill these requirements.
After attending this seminar, you will be familiar with the fundamentals of risk management for medical devices in accordance with ISO 14971:2019 and the harmonized EN ISO 14971:2019/A11:2021. You will also learn about the new features of the updated ISO/TR 24971:2020 guideline. You will be able to correctly implement the risk management process in your company, understand the objectives of the risk management plan, and know how to proceed with risk analysis and document the results correctly.
Using concrete case studies, you will have the opportunity on the second day to put what you have learned in theory into practice step by step and discuss any questions and difficulties that arise with the experts.
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:
- Access to Exemplar LINK
- 12-months of exclusive benefits including:
- One self-coaching assessment
- Extended learning content
- Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
- Access to an exclusive LinkedIn Community
- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.
Learn more about TÜV SÜD's Exemplar Global Accreditation today
In this online, Instructor-led training through a mix of practical activities, classroom learning and group discussion, participants will learn risk management terminology and the stages of the risk management process. And in our practical workshop, you will create a risk management plan, apply tools for risk assessment and risk control, conduct a benefit-risk analysis, create a risk management report, and assess production and post-production information for possible action.
This seminar addresses internationally valid standards and can also be held abroad.
- Instructor-led in a virtual classroom
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
Participants who attend at least 90% of the total training duration will receive an official Certificate of Attendance from TÜV SÜD Academy.
1. What is this training about?
This course provides a comprehensive understanding of risk management for medical devices based on ISO 14971:2019 and related guidance (ISO/TR 24971). It focuses on how to identify, evaluate, control, and monitor risks throughout the product lifecycle.
2. Why is risk management important for medical devices?
Risk management is a regulatory requirement worldwide (e.g., EU MDR, ISO 13485) and is essential to ensure patient safety, product compliance, and successful market access.
3. Who should attend this course?
This training is ideal for professionals such as:
- Medical device manufacturers and suppliers
- Quality management (QM) and regulatory affairs professionals
- Product developers and engineers
- Safety officers and consultants
- Anyone involved in risk analysis or compliance activities
4. What will I learn in this course?
You will learn how to:
- Implement a risk management system compliant with ISO 14971
- Perform risk analysis, evaluation, and control
- Define and apply risk acceptance criteria
- Conduct benefit-risk analysis and residual risk evaluation
- Create and maintain risk management documentation
5. Which standards and regulations are covered?
The course primarily covers:
- ISO 14971:2019 (risk management standard)
- ISO/TR 24971:2020 (guidance)
- EN ISO 14971 harmonization (EU MDR/IVDR)
- Links to ISO 13485 and global regulatory frameworks (FDA, MDR, etc.)
6. Are practical exercises included?
Yes. Participants will:
- Develop a risk management plan
- Perform hazard identification and risk analysis
- Apply risk control measures
- Evaluate residual risks and benefit-risk balance
7. Will I learn specific risk analysis tools?
Yes. The course introduces widely used tools such as:
- FMEA (Failure Mode and Effects Analysis)
- FTA (Fault Tree Analysis)
- ETA, HAZOP, HACCP, and more
8. Is prior experience required?
No strict prerequisites are required. However, basic knowledge of:
- Medical devices
- Quality management systems
is beneficial.
9. How does this training help with regulatory compliance?
The training helps you:
- Meet MDR and global regulatory requirements
- Prepare for audits and inspections
- Ensure proper documentation and traceability
- Align risk management with clinical evaluation and QMS
10. Will I receive a certificate?
Yes. Participants who meet attendance criteria receive a TÜV SÜD Certificate of Attendance.
11. Is there an exam?
The standard ISO 14971 training focuses on practical learning and implementation. A formal exam is typically not required for the attendance certificate.
12. What are the key benefits of attending?
- Understand and apply ISO 14971 effectively
- Improve product safety and risk control
- Reduce quality and compliance risks
- Gain industry-recognized training from TÜV SÜD
- Enhance your career and regulatory expertise
13. How is risk defined in ISO 14971?
Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm.
14. What is included in the risk management process?
The process includes:
- Risk analysis
- Risk evaluation
- Risk control
- Residual risk assessment
- Post-market monitoring
- Risk management reporting
15. Does the course cover post-market surveillance?
Yes. It includes how to:
- Collect and review production and post-market data
- Update risk assessments based on real-world evidence
- Maintain compliance throughout the product lifecycle
16. Can I apply what I learn immediately?
Absolutely. The training is practically oriented, enabling you to immediately:
- Implement risk management processes
- Improve documentation
- Apply tools in real projects
17. Is this training recognized internationally?
Yes. TÜV SÜD is a globally recognized certification and training provider, and ISO 14971 is an international standard.
18. Can this course be combined with other trainings?
Yes. This course is part of a broader medical device training pathway, including:
- ISO 13485 (QMS)
- Internal auditing
- CAPA and process validation
- Regulatory affairs programs
Specialist lecturers from the TÜV SÜD Academy