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.

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.

Frequently asked questions

If you have a question about the TOPRA MSc, you may find the answer on our FAQ page . You can also contact Zamzam, our postgraduate programmes administrator, for additional details.

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
20/11/2023Design Development and Certification of Medical DevicesThis Masterclass (also module 14 of the MSc Regulatory Affairs) 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.MD142023
20/11/2023Design 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.MSC142023O
06/12/2023Drug Device Combinations and Other TechnologiesModule 18 of the MSc and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product.MDM182023
06/12/2023Drug Device Combinations and Other TechnologiesModule 18 of the MSc and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product.MSCM1823O
24/04/2024Clinical 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.MSCM152024
24/04/2024Clinical 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.MSCM1524O
26/06/2024The 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.MDINTRO24