Learning through doing, with experts at your side.
Our diploma in medical device quality assurance and regulatory affairs has been specifically designed to address the learning requirements of the modern day professional involved in the medical device product lifecycle.
The diploma offers eight core modules available through specific public training, distance learning via workbooks and accreditation of prior learning.
Module 1 ~ Medical Device Regulatory Frameworks
Module 2 ~ Medical Device Risk Management, Design, Development and Product
Module 3 ~ Medical Device Clinical Investigation and Evaluation
Module 4 ~ Preparing and Managing Technical Documentation for Medical Devices
Module 5 ~ Implementing and Management Medical Device Quality Management Systems
Module 6 ~ Medical Device Post-Market Surveillance and Vigilance
Module 7 ~ Working with Regulatory Agencies, Scientific Agencies and CRO’s
Module 8 ~ Medical Device QARA Professional management and behavioural skills
If you have any queries please click here to contact Andrea James