19029 Regulatory Compliance for Medical Devices

Lectures, interactive discussions and case studies provide in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. Emphasis is placed on using the principles in the medical device quality system (QS) regulation and ISO 13485 as tools to take a process-oriented, risk-based approach to compliance, while achieving strategic business objectives in today's dynamic regulatory environment. Students learn about key quality system regulation processes and how to recognize non-compliance. The instructor provides insight into putting an effective CAPA system in place and using it as an improvement tool. Current industry trends, FDA initiatives and best practices when interacting with regulatory agencies are also discussed.

This course is suitable for professionals in the medical device sector who are responsible for compliance, regulatory affairs, project planning, design and development, technology transfer, QA, R&D and manufacturing. Corporate management will find the course helpful in understanding the legal and system requirements necessary for compliance with the quality systems regulation and the penalties for non-compliance.

Certificate Program in Regulatory Affairs