ISO 14971: Risk Management For Medical Devices

In the field of medical device manufacturing, managing risks isn’t just a regulatory requirement; it is a fundamental aspect of ensuring patient safety and product efficacy. This certified training is designed to equip professionals with the expertise required to master the complexities of risk management in accordance with the ISO 14971 standard.

Who should enroll ? This course is essential for any medical device professional looking to expand their knowledge of comprehensive risk management processes and their interactions with the entire lifecycle of a medical device. Recommended for Quality Managers, Regulatory Affairs Specialists, and development team members of a medical device, it offers critical insights into ensuring product safety and compliance with global standards.

Topics outlined in the course :

• How do you use the 5X5 Matrix for risk assessment in medical device manufacturing?
• What are the key elements of a robust Risk Management Policy?
• What steps are involved in implementing a comprehensive Risk Management Plan?
• How is the Failure Mode and Effects Analysis (FMEA) used in risk management for medical devices?
• How do you conduct effective risk analysis and evaluation to identify and mitigate potential hazards?
• How can risks be controlled and what are the key strategies for effective risk mitigation?
• How do you assess the overall residual risk after implementing control measures?
• What are the essential components of a Risk Management Report ?
• How does risk management influence both the production and post-production activities of medical devices?
• How does effective risk management impact the Quality Management System (QMS) ?

This is a comprehensive certified course covering all required elements of ISO 14971 through an interactive online experience. Case studies and quizzes follow each lesson to reinforce learning. Upon completion, participants will receive an internationally recognized GxP Training certificate, accredited with CPD/CEU credits.

Curriculum:

Introduction

Lesson 1: 5X5 Matrix, Risk Management Policy, and Risk Mitigation Keys

Lesson 2: Risk Management Process & Risk Management Plan

Lesson 3: FMEA in Risk Management

Lesson 4: Risk Benefit Analysis & Risk Management Report

Conclusion

Glossary

Evaluation