Medical Technology Regulatory Affairs MSc - part-time
Course content
The course content has been designed to provide students with the knowledge, skills and practical experience they need for an enhanced career in regulatory affairs.
Each module lasts three days, and a maximum of four modules can be studied each year. Four of the eight modules run in year one and the remaining fur modules run in year two.
The topics covered in the modules are as follows.
Modules
1 Principles of European Medical Technology Regulatory Affairs (RA) Dates TBC
2 Design, Development and Testing of Medical Technology Dates TBC
3 Clinical Evaluation of Medical Technology 13 - 15 March 2012
4 Management of Regulatory Affairs and its Contribution to the Medical Product Lifecycle 12 - 14 June 2012
5 Medical Device Vigilance, Post-Market Surveillance (PMS) and Risk Management 11- 13 September 2012
6 Regulation of Drug-Device Combinations and Other Medical Technology Products 11- 13 December 2012
7 US Regulation of Medical Technology Dates TBC
8 Regulatory Strategy in the Market Place Dates TBC
For those students who do not wish to complete the full MSc or have a specific interest, individual modules may be attended as standalone three-day short courses.
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Next short course and module:
- Clinical Evaluation of Medical Technology 13 - 15 March Cranfield University UK



