Formerly "Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements"
Stay current in the evolving medical device regulatory landscape with this hands-on, interactive course. Designed for both new graduates and experienced professionals, the course focuses on the FDA's Quality Management System Regulation (QMSR) amendment (21 CFR 820) and its alignment with ISO 13485:2016, emphasizing a risk-based, process-driven approach to compliance.
Through lectures, interactive discussions, and case studies, participants learn to apply quality system principles to real-world scenarios, including inspection readiness, noncompliance challenges, and effective CAPA management. The course highlights how the updated QMSR aligns with ISO 13485:2016, enabling participants to leverage quality systems as strategic business tools-not just compliance obligations.
Key topics include risk-based quality system processes, regulatory intelligence, the Medical Device Single Audit Program (MDSAP), and practical approaches to achieving and sustainable compliance. By the end of the course, participants will have the knowledge and practical skills to navigate the updated QMSR framework and ISO 13485:2016 requirements effectively, applying them directly in their regulatory, quality, or operational roles..
UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 25 contact hours
Additional Information
AI* - This course discusses the ways in which AI tools can support quality compliance and regulatory intelligence efforts in an organization.
