Risk Management and Risk Analysis for Medical Devices as per ISO 14971:2019
![]() | Top-selling course |
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].
Who Should Attend?
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
Course Agenda
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
- Riskassessment
- Risk control
- Assessment of the overall residual risk
- Downstream phases and the impact of the risk analysis on the QM system
- Riskmanagement 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
Course Description
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.
Benefits
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 todayMethodology
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