Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements

Course Description

Through a series of lectures, interactive discussions and case studies, this course provides in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. The course emphasizes using the principles of the medical device quality system (QS) regulations 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. You will learn about key processes in the quality system medical device regulation (21 CFR 820) and ISO 13485, while learning how to address noncompliance challenges from a practical standpoint. The instructor provides insight into implementing an effective CAPA system and using it as an improvement tool. The course also discusses current industry trends, FDA initiatives, best practices for interacting with regulatory agencies, and a brief overview of the FDA Quality System Inspection Technique (QSIT) and Medical Device Single Audit (MDSAP) programs.