Medical Devices Quality Assurance & Regulatory Affairs

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Students explore the innovative and rapidly expanding medical devices industry including roles and responsibilities from the Quality Assurance (QA) and Regulatory Affairs (RA) perspective. This highly interactive course draws upon real-life case studies as well as the expertise and experiences of instructors and guest speakers currently or previously working in the medical devices industry. Students learn how to interpret regulatory requirements and apply the key elements, processes, and best practices of a strategic risk-based QA/RA program required for timely regulatory clearance of safe and effective medical devices into Canada, USA and Europe markets. Students discover the core elements of a robust Quality Management System (QMS), including processes such as document and record management, design control, risk management, internal auditing, supplier management, complaint handling amongst others. Students learn to build effective communication and foster relationships to engage all stakeholders for QMS certification and regulatory compliance using international standards for medical devices (ISO 13485 and ISO 14971). Students acquire the required knowledge and skills to work with Health Canada, the US Food and Drug Administration (FDA), and European Notified Bodies.

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