Application of Risk Management for Medical Devices based on ISO 14971:2019 Standard

This training program will provide participants with an in-depth understanding of medical device risk management standards according to ISO 14971:2019 and ISO/TR 24971:2020. It will enable participants to understand how to implement risk management to comply with regulatory expectations while presenting the technical documentation.

At the end of this course, you will be able to:

• Demonstrate compliance with regulatory requirements.
• Ensure product development with desired quality and safety standards.

• Introduction to ISO 14971:2019
• Links to regulatory requirements
• Understanding of ISO 14971:2019 risk management for medical devices 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
• Exercise
• Online examination

• Product Risk Managers
• Regulatory Managers
• Quality Assurance Professionals
• R&D Professionals
• Engineers
• Operational Managers
• Manufacturing Managers

Our training partners are experts in the industry, having hands-on experience in conducting live virtual/classroom training programs, in-depth knowledge of the standards and regulations that affect your business and applying these standards across various industry domains. Our training partners do their best to provide the best learning experience.

• Learn how to plan better and create a framework for risk management.
• Demonstrate compliance with regulations.
• Have a structured approach while implementing risk management measures.
• Learn the overview of risk management activities.
• Ensure product development with desired quality and safety standards.
• Integration of risk management into an existing Quality Management System

The Application of Risk Management for Medical Devices based on ISO 14971:2019 Certification can be obtained by enrolling and attending our instructor-led training program. Post-completion of the course, participants are required to attend an examination containing multiple-choice questions to obtain the certificate. Participants scoring as per the passing criteria would be awarded a successful completion certificate by TÜV SÜD South Asia.

• Exam Type: Multiple choice questions
• Exam Questions: 50
• Exam Time: 75 minutes
• Required number of points: 30 points
• Maximum number of points: 50
• Aids: Open Book
• Passing Criteria: 60%

1. Are there any prerequisites to apply for the Application of Risk Management for Medical Devices course?
Candidates are recommended to have prior experience in relevant fields applicable as per the training program.

2. How does Risk Management for Medical Devices Training help me?
The two-day – Medical Device Risk Management training aims to help candidates in the quality and regulatory field gain in-depth knowledge of the requirements of ISO 14971:2019 Standard. This interactive training is where participants engage in various exercises and tasks throughout the two days. It helps participants gain practical knowledge and apply this to their day-to-day work.

3. Can I get the course content?
We share the training content with all participants before the start of the training.

4. Can I get the recording of the sessions?
We conduct live, interactive training sessions. Recording of the training sessions is not permitted.

5. When does the final examination take place?
The final examination access is sent to your registered email ID on the last day of the training program. The access remains valid for 72 hours after the training is completed. Participants must submit the online examination within the stipulated time. It will be considered the first attempt if the participant fails to submit the examination within the stipulated time.
For Lead Auditor Courses: The final examination is conducted on the final day of the training program.

6. How long does it take to get the e-certificate?
Once you have submitted the final examination, it is sent for evaluation. General evaluation requires three weeks to be completed. The results, followed by the e-certificate, are released after the due evaluation is completed.

7. How can I get the physical copy of the e-certificate?
We provide a physical copy of the e-certificate at an additional charge. You may email us requesting a physical copy after receiving the e-certificate.

8. Can I take the examination without attending the course?
As per the guidelines, participants must attend the complete training to be eligible for the final examination.

9. What if I fail the examination?
Participants are eligible to take a second attempt if required. The second attempt at the final examination is provided at an additional charge. You may email us if you must appear for a second attempt for the final examination.

10. How do I register for this course?
You may register by paying the training fees on the e-Store. Following this, you will receive a confirmation about your enrollment in the preferred batch.

11. Is there any refund policy for the paid fees?
You may write us an email requesting a refund of your fees. Any cancellations or refunds must be informed at least two weeks before the training dates.

• Stryker Corporation
• Boston Scientific
• Draeger India Pvt. Ltd.
• Medtronic India Pvt. Ltd.
• Tata Consultancy Services
• Meril Healthcare Pvt. Ltd.
• Thermo Fisher Scientific
• HCL Technologies Ltd.
• Siemens Healthieers
• Becton, Dickinson & Company