MSc Regulatory Affairs (Medical Devices)

TOPRA has developed an exciting new MSc in Medical Devices. It provides the opportunity for people to combine modules in both pharmaceutical and medical technology regulatory affairs, something that might be particularly beneficial for those interested in drug-device combination products, as well as consultants and members who are in the early stages of their career and wish to have a foot in both camps.

To join the programme, please contact Kay, our postgraduate administrator.

About the MSc

Both our MSc Regulatory affairs (Medical Devices) and MSc Regulatory affairs (Medicines) have been validated by the University of Hertfordshire. Students may be eligible for a distinction or commendation, depending on their final results on completion of their studies, after a maximum time period of six years. More

Entry requirements

Entry requirements for the programme normally specify a Science degree (at the equivalent of a 2.2 or above) and that the student has obtained basic knowledge about regulatory affairs processes, documentation in the healthcare industry and has professional skills which include attention to detail, organisation and communication in an area of healthcare product development and lifecycle management. Read more about TOPRA MSc entry requirements.

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Frequently asked questions

If you have a question about the TOPRA MSc, you could find the answer on our FAQ page.

 Fees

Download: MSc Fees PDF

Experiences of the MSc

Some of our graduates and module leaders talk about their experiences of the Regulatory Affairs MSc.

Upcoming modules

Begin DateTitleDescription
23/03/2022Design, Development and Certification of Medical DevicesThis Masterclass is also module 14 of the MSc Regulatory Affairs and will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.MD1422
23/03/2022Design, Development and Certification of Medical DevicesThis Masterclass is also module 14 of the MSc Regulatory Affairs and will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.MSC142022O
23/05/2022Clinical Evaluation of Medical DevicesThis Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.MSCMD1522
23/05/2022Clinical Evaluation of Medical DevicesThis Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.MSMD1522O
05/07/2022The Medical Device Introductory Course(Module 13 of the MSc Medical Devices) Providing those new to Medical Device Regulatory Affairs with an understanding of the regulatory requirements for medical devices in the EU.INTROMD
05/09/2022Post-Market Surveillance and Vigilance for Medical DevicesThis Masterclass is also Module 16 of the MSc Regulatory Affairs and will help to define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the life cycle of a medical device. This course will focus on meeting European requirements.MD162022
02/11/2022Regulatory & Related Activities Through the Device LifecycleThis Masterclass is also Module 17 of the MSc Regulatory Affairs and will provide regulatory affairs professionals with insight into the strategic issues affecting the commercial and regulatory maintenance of a medical device throughout its lifecycle, with focus on post-launch activities and future pressures.MD172022

Terms and conditions

Booking conditions for the MSc Regulatory Affairs modules.