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

To be admitted to the MSc, candidates will normally need to have 2 years’ experience in regulatory affairs and hold a science degree or equivalent. Read more about TOPRA MSc entry requirements.

Downloads

Frequently asked questions

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

Experiences of the MSc

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

Fees

TOPRA MSc fees guide 2018-2019
(Microsoft Word Document)

Upcoming modules

Begin DateTitleDescription
10/07/2019The 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.INTROMD19
20/11/2019Data Management and Digitalisation in Regulatory AffairsThis Masterclass will provide you with  the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance.  This is also Module 12 of the TOPRA MSc Regulatory Affairs.MSCM122019
20/02/2019Regulation of In Vitro Diagnostic Medical DevicesThis Masterclass primarily focused 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 such as the US, Japan, China and Brazil. This is also module 19 of the TOPRA MSc Regulatory Affairs.MSCM19
29/05/2019Regulation 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 is also Module 20 of the TOPRA MSc Regulatory Affairs.MSCM2019
25/09/2019US 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. Additionally it will provide you with an understanding of a globally important market in addition to the knowledge of the EU that the rest of the course provides.This is also Module 21 of the MSc Regulatory Affairs.MSCM212019

Terms and conditions

Booking conditions for the MSc Regulatory Affairs modules.

2015 graduate celebration