Change Management for Medical Devices

This course is designed to equip medical device professionals with the knowledge and skills necessary to navigate the complex landscape of regulatory compliance and best practices in change management. Gain insights on best practice as you learn how to implement effective change management strategies that enhance device safety and quality for improved patient outcome.

Course description

By attending this course, you will gain a deep understanding of critical regulations, including FDA’s 21 CFR Part 820 and ISO 13485:2016, which govern the development and marketing of medical devices. We will explore the importance of risk management, documentation, and traceability in ensuring that all changes maintain the highest standards of safety and performance. Through interactive sessions, you will learn how to effectively collaborate across departments to implement changes smoothly and efficiently.

Our course will also cover the integration of change management into your Quality Management System (QMS) to ensure systematic control and monitoring. Additionally, we will emphasize the significance of post-market surveillance in identifying and addressing potential issues. By the end of this course, you will be well-prepared to manage changes in medical device development and marketing, ensuring compliance and safeguarding patient safety.

Learning objectives

• Understand Regulatory Requirements: Gain a comprehensive understanding of key regulations, including FDA’s 21 CFR Part 820 and ISO 13485:2016, and their implications for change control in medical device development and marketing.
•  Implement Effective Risk Management: Learn to assess and manage risks associated with changes to ensure the safety and performance of medical devices.
• Maintain Thorough Documentation: Develop skills to create and maintain detailed records of changes, ensuring traceability and compliance with regulatory standards.
• Foster Cross-Functional Collaboration: Understand the importance of collaboration across departments and learn strategies to facilitate effective communication and teamwork during the change management process.
• Integrate Change Management into QMS: Learn how to incorporate change control processes into your Quality Management System (QMS) to ensure systematic and controlled implementation of changes.
• Conduct Post-Market Surveillance: Gain insights into the importance of monitoring device performance post-market and learn how to identify and address issues that may arise.
• Enhance Training and Communication: Develop strategies to effectively train and communicate with relevant personnel about changes, ensuring they understand the implications and can implement changes correctly.
• Apply Best Practices in Change Management: Learn and apply industry best practices for managing changes in medical device development and marketing to ensure compliance and protect patient safety.

Course Outline

• Introduction to change control & the Change Control Process -Overview on end to end process spanning initiation of change requests, evaluation and risk assessment, approval process, implementation and documentation; verification and closure
• Introduction to Regulatory requirements for change control – overview of Overview of FDA’s 21 CFR Part 820 and ISO 13485 and the importance of compliance in medical device development and marketing
• Roles and Responsibilities as part of Cross-Functional Collaboration – Importance of collaboration across departments with strategies for effective communication and teamwork
• Risk management in Change Control – Identifying and assessing risks associated with changes, strategies for mitigating risks, case studies on risk management in change control and continuous monitoring.
• Documentation and Record Keeping: required documentation, maintaining change control records, traceability and audit trails.
• Case Studies and Practical Exercises
• Common Challenges and Solutions: Overcoming Resistance to Change, Ensuring Stakeholder Buy-in, Continuous Improvement
•  Conclusion and Q&A: Review of Key Concepts, Final Questions and Answers

Who should attend

This training is ideal for Quality assurance professionals, Regulatory affairs specialists, Design and development engineers, Manufacturing and process engineers and Project managers, and supply change managers working in the medical device industry

Need of prior knowledge/experiences

At least one year of experience in the Medical Device industry in one of the roles listed above (or a similar role).

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