Manufacturing and Quality Management System for Medical Devices (Classroom and Asynchronous e-learning)
Training Provider: NATIONAL UNIVERSITY OF SINGAPORE
Course Reference: TGS-2024044127
S$1,620
Original: S$5,400
Save S$3,780
About This Course
On successful completion of this course, you will be able to explain the fundamentals of Good Manufacturing Practices for medical technology, articulate the concepts and basis of Quality Management Systems in relation to regulatory requirements (in particular the ISO 13485), and describe key quality management processes for raw materials, sites, and facilities in manufacturing of medical devices.
What You'll Learn
One of the key factors for ensuring quality of medical technology is the regulatory control of manufacturing, which is supported by a robust Quality Management System for continued compliance during audits. Thus, to maintain product quality after entering the market, a reliable system must properly monitor and regulate these manufacturing activities, which is pivotal to a strategy for successful product design and development. This course covers the production, quality management systems, and regulatory activities related to quality assurance of medical technology in regulated markets.
Entry Requirements
Bachelor's degree, basic understanding or relevant experience in health products regulation.
Course Details
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