Application of Risk Management for Medical Devices

Training duration: 2 Days

Course Overview 

This course equips participants with practical knowledge on performing risk analysis and risk evaluation of medical devices to demonstrate compliance with ISO 14971:2019 standard requirements. You will learn how to seamlessly integrate risk management processes into an existing Quality Management System (QMS), enhancing your ability to meet evolving regulatory expectations. Designed and delivered by industry experts with extensive global experience in the Medical Devices sector, this program offers globally recognized certification and is attended by over 1,000 participants annually. Engage with international peers, broaden your network, and gain cross-learning opportunities through interactive sessions. The course also covers production and post-production risk management activities essential for Medical Device Manufacturers. 

What Will You Learn? 

This training provides a comprehensive understanding of medical device risk management standards in alignment with ISO 14971:2019 and ISO/TR 24971:2020. You will gain the skills needed to implement effective risk management strategies that comply with regulatory expectations and produce robust technical documentation. 

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

• Demonstrate compliance with relevant regulatory requirements
• Ensure product development meets stringent quality and safety standards 

Course Outline 

• Introduction to ISO 14971:2019
• Regulatory requirements and their linkage to ISO 14971
• Understanding and implementing the ISO 14971:2019 risk management standard
• General requirements for a risk management system
• Risk analysis methodologies
• Risk evaluation processes
• Overall residual risk evaluation
• Risk management review mechanisms
• Production and post-production risk management activities
• Integration of risk management within Quality Management Systems (QMS)
• Practical exercises
• Online examination

Who Should Attend? 

• Product Risk Managers
• Regulatory Affairs Managers
• Quality Assurance Professionals
• Research & Development (R&D) Professionals
• Medical Device Engineers
• Operational Managers
• Manufacturing Managers

Learning & Career Benefits 

• Develop skills to plan and establish a robust risk management framework
• Gain capability to demonstrate compliance with regulatory requirements
• Adopt a structured approach to risk management implementation
• Understand the complete risk management lifecycle
• Contribute to ensuring development of safe, high-quality medical devices
• Efficiently integrate risk management activities into your existing QMS

Examination & Certification 

Certification is awarded upon successful completion of the instructor-led training and passing the final examination. The exam consists of 50 multiple-choice questions to be completed within 75 minutes, with a minimum pass score of 60% (30 out of 50 points). The exam is open book to facilitate application of knowledge. Upon passing, participants will receive a certificate of successful completion accredited by TÜV SÜD South Asia.

Get in touch with us to know more. 

Business address 

TÜV SÜD Bangladesh (Pvt.) Ltd.

Update Tower, Level- 12, 8 & 14, 01 Shahjalal Avenue, Sector-06, Uttara Model Town, Dhaka-1230, Bangladesh

Tel: +88 02 58954115, 58954120, Ext-119

Email: [email protected]