MSc Regulatory Affairs (Medical Devices)


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The TOPRA MSc Regulatory Affairs (Medical Devices) has been offered since 2018. It is the go-to qualification for both established and new entrants in the profession as it is designed and delivered by expert practising regulatory professionals from a wide range of specialties and backgrounds.

Its flexibility and range are ideal for regulatory professionals who are looking for a work-life balance and require a respected qualification that will support them in their career development. Its mix of theoretical, practical and strategic elements ensure that graduates are fully equipped to move rapidly, effectively and successfully along their desired career trajectory.

With up to 22 modules (+ dissertation) available, students can tailor their programme to suit their specific needs, including the option to take up to two modules from the Medicines Pathway. This part-time programme allows you six years to complete the required elements.

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.

Students can opt to take a Postgraduate Certificate after completing four modules or a Postgraduate Diploma on completion of eight modules.

Experiences of the MSc

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

Frequently asked questions

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

Entry requirements

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

How to apply

Please download the application form and submit the completed form as instructed in the application documentation.

Download the application

Forms, fees and documentation

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