96831 Medical Devices: Regulatory and Quality Systems Requirements6cp
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
This Subject sets out to provide students with an industry focused foundation in Medical Device (including In Vitro Diagnostic Medical Device) regulations, quality management systems and risk management as they apply to the life cycle of the device. The regulatory pathways for the major global markets, including US, EU and Australia, will be studied. An understanding of Quality Management System requirements and how they are implemented under ISO 13485 (1) and FDA 21 CFR Part 820 (2) will be developed. In addition, risk management as it applies to, and is implemented within, the Quality Management System, via ISO 14971 (3), will be covered. These topics will give students foundational knowledge into how a medical device is safely and compliantly designed & developed, manufactured and subsequently marketed in the specified major global markets.
1. ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
2. FDA 21 CFR Part 820 - Quality System Regulation
3. ISO 14971:2019 Medical Devices - Application of Risk Management To Medical Devices
Detailed subject description.