Awareness Training Program on ISO 14971:2019
With this interactive training program, you will:
- Receive a recognised certificate from TÜV SÜD demonstrating your understanding of ISO 14971:2019 requirements and risk management principles for medical devices.
- Gain a better understanding of ISO 14971:2019 requirements and their implementation in risk management processes for medical devices.
- Develop the knowledge and skills necessary to apply risk management principles effectively within your organisation's medical device development and manufacturing processes.
- Network with professionals in the healthcare and medical device industry, sharing experiences and building relationships with peers facing similar regulatory requirements.
- Enhance your professional qualifications and broaden your career prospects in the medical device sector by acquiring expertise in the latest risk management standards.
- Contribute to improving patient safety and product quality by learning how to effectively implement risk management practices in medical device development and manufacturing.
- Acquire the ability to identify and mitigate potential risks associated with medical devices, helping your organization maintain compliance with regulatory requirements and industry best practices
What will you learn?
At the end of the course, you will:
- Have better planning and framework of risk management
- Demonstrate compliance to regulations
- Have structured approach while implementation
- Learn the overview of risk management activities
- Ensure product development with desired quality and safety standards
- Integrate risk management into an existing Quality Management System
Course outline
In this program, you will learn the following:
- Introduction to ISO 14971:2019
- Links to regulatory requirements
- Understanding of ISO 14971:2019 standard and implementation
- General requirements for risk management system
- Risk analysis
- Risk evaluation
- Evaluation of overall residual risk
- Risk management review
- Production and post-production activities
- Application of risk management in QMS
Who should attend?
The course is specially designed for:
- Product Risk Managers
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Project Managers
- Operations Managers
- Manufacturing Managers
- Engineers
Learning & Career Prospects
The career prospects for the Awareness Training Program on ISO 14971:2019 are outstanding. As the medical device industry prioritises risk management, there is a growing need for professionals proficient in understanding and applying ISO 14971:2019 standards.
Career prospects include:
- Medical Device Risk Management Specialist
- Regulatory Affairs Specialist
- Quality Assurance Manager
- Compliance Officer
- Medical Device Safety Consultant
- Internal Auditor/External Auditor
Trainer Profile
The course content and structure are developed by the domain experts from TÜV SÜD. With immense experience and knowledge of the relevant standards, our team of product specialists and technical experts at TÜV SÜD have developed the course content based on the current business landscape and market requirements.
Examination & Certification
Upon completing the Awareness Training Program on ISO 14971:2019 course, participants will be assessed through a 50 marks written examination (open book) at the end of the course.
Minimum passing % criteria: 70%
Certification details:
Participants who score 70% and above in the written examination will be issued a TÜV SÜD South Asia’s course completion certificate. Unsuccessful candidates will be issued a certificate of attendance.
FAQ
1. Can I also attend e-learning courses on top of attending the Awareness Training Program on ISO 14971:2019 course?
Yes, you can register for any e-learning course at TÜV SÜD.
2. How do I enroll for the Awareness Training Program on ISO 14971:2019 course?
To enroll, please click on "Buy now" and check out your cart.
3. What is the Awareness Training Program on ISO 14971:2019 course methodology?
Participants will learn through lectures, case studies, group exercises and discussions.
4. Can I get a refund if I cancel my enrolment?
- If you communicate the cancellation to us by email within 14 days before the confirmed training date, we will not provide a refund for the training.
- If you communicate the cancellation to us by email more than 14 days before the confirmed training date, we will provide a 50 % refund for the training.
5. Are there any tests in the middle of the course?
There are no in-between assessments, but case studies will be included in the ISO 14971:2019 Awareness course. Participants will be assessed through a 50 marks written examination (open book) at the end of the course.