Introduction to Medical Devices & Regulations
Get a foundational understanding of medical devices, their classifications, development lifecycle, and regulatory frameworks (FDA, CE, MDR). Ideal for beginners entering the medtech space.
Medical Devices
Post-Market Surveillance & Vigilance in Medical Devices
Understand how post-market surveillance, incident reporting, and corrective actions maintain medical device safety and performance.
Design and Development of Medical Devices
Explore the design control process, including risk analysis, usability engineering, and human factors during device development.
Quality Management Systems in Medical Devices (ISO 13485)
Learn how to implement and manage a Quality Management System (QMS) in compliance with ISO 13485 standards, including documentation, CAPA, and audits.