Regulatory Control Of Healthcare Products Medical Devices

AY2017/2018 Semester 1

This course focuses on 3 main areas: 1. Introductory to the principles of safety, quality and effectiveness, differences in regulatory framework in some major jurisdictions, healthcare product definitions, and manufacturer responsibilities. Major adverse incidents led to the enactment of healthcare products laws. 2. Discussion on good manufacturing practice, quality management system and product testing/validation. Understanding experimental design and data analysis is one of the key concepts. 3. Applying risk management concepts to medical device examples through practical casework.