MSc in Medical Technology Regulatory Affairs
In today's competitive and highly regulated healthcare environment, it is essential for companies to bring new products to the market quickly – and to keep them on the market. Excellence in managing regulatory issues is therefore a key strategic advantage to healthcare companies.
A good regulatory affairs professional plays an important part in coordinating scientific endeavor with regulatory demands throughout the life of a product and yet, to date, there has been no recognised way to formalise skills in this field.
Why Cranfield’s MSc in MTRA?
Through a collaboration between Cranfield Health and The Organisation for Professionals in Regulatory Affairs (TOPRA), for the first time, an MSc qualification is available to provide a systematic framework for the study of regulatory affairs in the field of medical technology.
With this formal qualification, it is now easier to demonstrate skills to employers and peers. Employers benefit through the development of personnel to an increased level of competence and professionalism, whilst those involved in recruiting find it easier to identify proficiency using this gold standard.
Course Structure
The MSc course is based on eight compulsory three-day modules plus an integrating portfolio and a research project presented as a thesis. The MSc may take up to a maximum of three years to complete.
Available on a part-time basis only, the course is designed to be flexible in order to fit around existing employment and responsibilities. For even greater flexibility, and for professionals with a specific interest, individual modules may be attended as standalone short courses, without the need to register for the full qualification.
The course is also available at PgCert and PgDip levels. Find out more about some of the latest graduates.
Module Outline
- Principles of European Medical Technology Regulatory Affairs (RA)
- Design, Development and Testing of Medical Technology
- Clinical Evaluation of Medical Technology
- Management of Regulatory Affairs and its Contribution to the Medical Product Lifecycle
- Medical Device Vigilance, Post-Market Surveillance (PMS) and Risk Management
- Regulation of Drug-Device Combinations and Other Medical Technology
Products
- US Regulation of Medical Technology
- Regulatory Strategy in the Market Place
Find out more:
For full details visit Cranfield University's website.
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This degree is validated and awarded by Cranfield University, UK. For further details please contact Cranfield University, Bedfordshire MK43 0AL, tel: +44 (0) 1234 758008 or email: enquiries.health@cranfield.ac.uk website: www.cranfield.ac.uk/health