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 Rosely, our Head of Training and Qualifications, 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
04/12/2024Regulatory Strategy in the Post Market PhaseThis Masterclass is also Module 17 of the MSc Regulatory Affairs (previously know as Regulatory and Related Activities Through the Device Lifecycle) 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.MD172024
04/12/2024Regulatory Strategy in the Post Market PhaseThis Masterclass is also Module 17 of the MSc Regulatory Affairs (Previously titled Regulatory & Related Activities Through the Device) 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.MD172024O
03/06/2025US Regulation of Medical DevicesThis Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. This Masterclass is  also Module 21 of the MSc.MSCM2125
03/06/2025US Regulation of Medical DevicesThis Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. This Masterclass is also Module 21 of the MSc.MSCM2125O
16/06/2025The Medical Device Introductory CourseThis Masterclass will provide those new to Medical Device Regulatory Affairs with an understanding of the regulatory requirements for medical devices in the EU. This Masterclass is  also Module 13 of the MSc.MDINTRO25
08/09/2025Design Development and Certification of Medical DevicesThis Masterclass 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. This Masterclass is  also Module 14 of the MSc.MSC142025O
08/09/2025Design Development and Certification of Medical DevicesThis Masterclass  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. This Masterclass is  also Module 14 of the MSc.MSCM142025
20/10/2025Regulation of In-Vitro Diagnostics Medical DevicesThis module primarily focusing on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions. This Masterclass is also Module 19 of the MScMSCM1925
20/10/2025Regulation of In-Vitro Diagnostics Medical DevicesThis Masterclass primarily focusing on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions. This Masterclass is also Module 19 of the MSc.MSCM1925O
02/12/2025Regulation of Electrical, Electronic and Software DevicesThis Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impact of the regulations on product stakeholders. This Masterclass is also Module 20 of the MSc.MSCM2025O
02/12/2025Regulation of Electrical, Electronic and Software DevicesThis Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impaally debate the commercial implications and the impact of the regulations on product stakeholders.MDM202025