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Healthcare Regulatory Affairs

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MSc in Medical Technology Regulatory Affairs

TOPRA

In today's competitive environment the reduction in the time taken to reach market is critical to a product's – and hence a company's success. The proper conduct of its regulatory affairs activities is, therefore, of considerable economic importance to a company.

Events such as failure to fully report all necessary data in the approval process or launch of a product bearing incorrect labelling, may easily result in the need for a product recall.

A good regulatory affairs professional plays an important part in coordinating scientific endeavour 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 Medical Technology Regulatory Affairs?

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.

Medical Technology Regulatory Affairs course structure

The MSc course is based on eight compulsory modules plus a research project presented as a thesis.

Module Outline

  1. Principles of European Medical Technology Regulatory Affairs
    The regulatory path for placing medical devices on the market in the European Union and associated territories
  2. Design, Development and Testing of Medical Technology
    The suitability of the development programmes from a regulatory perspective
  3. Clinical Evaluation of Medical Technology
    Clinical investigation, regulatory processes involved and alternative routes to demonstrate safety and effectiveness for the intended purpose of the device
  4. Management of Regulatory Affairs and its Contribution to the Medical Product Lifecycle
    Skills required to run a successful regulatory affairs department in order to optimise the contribution that regulatory affairs makes to the success of an organisation
  5. Medical Device Vigilance, Post-Market Surveillance (PMS) and Risk Management
    Terminology and concepts of vigilance, post-market surveillance and risk management, their practical applications and integration into the medical device lifecycle
  6. Regulation of in-vitro Diagnostic Devices and Tissue Engineered Products (Dual Module)
    The regulatory framework relating to marketing in the EU and other territories. The nature of tissue-engineered products and their potential in regenerative medicine and the regulatory environment
  7. US Regulation of Medical Technology
    The US regulatory procedures as applied to medical devices
  8. Regulatory Strategy in the Market Place
    Strategic issues affecting the development, launch and commercial maintenance of a medical device product

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 or website: www.cranfield.ac.uk/health/courses.

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