Risk Management and Risk Analysis for Medical Devices as per ISO 14971:2019
This course is certified by Exemplar Global.
Stay up-to-date with the latest risk management standards in the medical device industry. Our online training course on ISO 14971:2019 covers all the normative references, general requirements for risk management systems, risk analysis, risk evaluation, and risk control.
As participant in this course:
- You will receive important know-how to be able to fulfil the obligation to introduce a risk management system for medical devices.
- You will be able to carry out standard-compliant risk analyses for medical devices.
- You will be able to implement ISO 14971 in your company.
- QM Representatives
- Safety experts for medical devices
- Product managers, designers
- Personnel in charge of approval and design
- Personnel in regulatory affairs
Day 1: Overview of the requirements for ISO 14971 and how to use them
- Applicable standards and normative references
- Terms and definitions
- General requirements for risk management system: process, responsibilities, competence of personnel, risk management plan and file
- Risk analysis
- Risk evaluation
- Risk control
- Evaluation of overall residual risk
- Risk management review and risk management file
- Production and post-production activities
- Impact of the risk analysis on the QM-system
Day 2: Practice-oriented workshop
- Practical implementation of the standards (ISO 14971)
- Implementation of risk analysis
- Developing of a risk management plan
- Different methods of risk analysis
- Carrying out a risk analysis
The importance of risk management in medical technologywill continue to grow in the future. Not only ISO 13485, but also the MDR andIVDR are based on sound risk management. A risk management system is and will remain a central legal requirement for all medical device manufacturersworldwide. A systematic risk management in accordance with ISO 14971 helps to meet these requirements.
After attending this seminar, you will know the basics ofrisk management for medical devices according to the applicable standards, basedon the ISO 14971:2019 standard in connection with the harmonized EN ISO 14971:2019/A11:2021. In addition, you will learn about thenew features of the updated ISO/TR 24971:2020 guideline. You will be able tocorrectly implement the risk management process in your company. You will knowthe objectives of the risk management plan as well as how to proceed with the riskanalysis and how to properly document results.
Using concrete case studies, youwill have ample opportunity on the second day to put the theoretical knowledgeyou have learned into practice step by step and to discuss any questions anddifficulties 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