Risk Management and Risk Analysis for Medical Devices as per ISO 14971:2019

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 training course, 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.

By attending this 2-day training course, participants will:

• Gain a comprehensive understanding of ISO 14971:2019 and its role in ensuring the safety and performance of medical devices throughout the product lifecycle.

• Learn how to establish and maintain an effective risk management process that meets the requirements of ISO 14971:2019, EN ISO 14971:2019/A11:2021, and applicable global regulatory expectations.

• Develop practical skills in conducting risk analyses, including hazard identification, risk estimation, risk evaluation, risk control, and residual risk assessment.

• Understand how to create and maintain key risk management documentation, including Risk Management Plans, Risk Management Files, and Risk Management Reports.

• Apply risk management principles to support compliance with MDR (EU 2017/745), ISO 13485, and other international regulatory requirements.

• Learn how to integrate risk management into product development and quality management systems, ensuring a proactive approach to product safety and regulatory compliance.

• Gain hands-on experience through practical workshops and case studies, allowing immediate application of theoretical concepts to real-world medical device scenarios.

• Understand the guidance provided by ISO/TR 24971:2020 and how to apply industry best practices for risk management implementation.

• Improve the ability to make informed benefit-risk decisions and justify risk acceptability throughout the medical device lifecycle.

• Strengthen preparedness for audits, inspections, and Notified Body reviews by understanding regulatory expectations for risk management documentation and evidence.

• Enhance cross-functional collaboration between Quality Assurance, Regulatory Affairs, R&D, Product Development, and Clinical teams through a common understanding of risk management principles.

• Contribute to the development of safer and more compliant medical devices while reducing the likelihood of product failures, complaints, recalls, and regulatory findings.

Upon Successful Completion

Participants will be able to confidently plan, perform, document, and maintain a compliant risk management process, conduct risk analyses in accordance with ISO 14971:2019, and apply risk-based thinking throughout the entire lifecycle of a medical device.

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.

There are no formal prerequisites.

Learning Path:

The eg-46-11-22-0011 – Risk Management and Risk Analysis for Medical Devices as per ISO 14971:2019 training course is a key element of the Manager Regulatory Affairs International – TÜV Learning Path:

Over two days, participants gain a comprehensive understanding of the principles and requirements of risk management for medical devices in accordance with ISO 14971:2019. The course equips professionals with the knowledge needed to identify hazards, evaluate and control risks, and establish risk management processes throughout the entire product lifecycle. As risk management is a fundamental regulatory expectation across global markets, this training provides essential competencies for ensuring the safety, performance, and compliance of medical devices.

This course complements the other modules within the learning pathway, including:

• Medical Devices Law – Regulatory Framework Conditions in Accordance with MDR (Not yet available),
• ISO 13485 Quality Management Systems for Medical Device Manufacturers with FDA QMSR (USA/Canada) — 2026 Update (eg-46-11-26-0019)
• Clinical Evaluation of Medical Devices – Foundation Course (46-11-22-0018), and
• Technical Documentation for Medical Devices (46-43-22-1003),

Together, these trainings provide a comprehensive understanding of the regulatory, quality, clinical, and technical requirements for medical devices. While the risk management course focuses on systematically identifying and mitigating device-related risks, the other modules address regulatory frameworks, quality management systems, clinical evidence generation, and technical documentation, creating a well-rounded competency profile for international regulatory affairs professionals.

This course is part of a modular training programme designed to build specialist knowledge in a structured and practical manner. By successfully completing all required modules within the learning path, participants can acquire the recognized qualification “Manager Regulatory Affairs International – TÜV.” This prestigious certification demonstrates comprehensive expertise in the key disciplines of medical device regulation and confirms the participant’s ability to support regulatory compliance, product safety, and successful market access in international medical device markets.

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

This course is certified by Exemplar Global.

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.