Regulatory Requirements For Medical Devices

This course covers the regulatory frameworks and quality management systems governing the design, manufacture, testing, and distribution of medical devices. Students examine standards such as ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management), as well as international regulations from the Saudi FDA, U.S. FDA, and European MDR. Emphasis is placed on product classification, technical documentation, clinical evaluation, and post-market surveillance. Through case studies, students learn how to ensure compliance and maintain device safety and effectiveness across global markets.

Course ID: BMEN 614