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

Upcoming modules

Begin DateTitleDescription
30/11/2022Regulatory Strategy From Development To the MarketplaceThis Masterclass is also Module 6 of the MSc regulatory Affairs and will enable you to consider and evaluate the practical regulatory aspects of regulatory strategy for commercialising products and maintaining the brand from the development stages to registration and throughout the product lifecycle. You will explore and critically debate the regulatory issues likely to arise prior to and during commercialising of products in order to be able to provide effective advice on such situations.MSCM62022O
01/02/2023US Regulation of Medical DevicesModule 21 of the MSc and Masterclass - This course 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.MSCM2123
01/02/2023US Regulation of Medical DevicesModule 21 of the MSc and Masterclass - This course 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.MSCM2123O
18/04/2023Regulation of In-Vitro Diagnostics Medical DevicesModule 19 of the MSc and 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.MSCM1923O
18/04/2023Regulation of In-Vitro Diagnostics Medical DevicesModule 19 of the MSc and 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.MDM1923
07/06/2023Regulation of Electrical, Electronic and Software DevicesModule 20 of the MSc and Masterclass: This 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.MDM202022
07/06/2023Regulation of Electrical, Electronic and Software DevicesModule 20 of the MSc and Masterclass: This 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.MSCM2023O
27/06/2023The 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.MD2023
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