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Master English Medicine & Health

Regulatory Affairs – Medical Devices MasterRegulatory Affairs – Medical Devices

Master of Science (M.Sc.)

About the Program

Regulatory Affairs is far more than just bureaucracy – it is the key to a successful market launch! Modern Regulatory Affairs Managers are evolving into strategic advisors for management. In the Regulatory Affairs (M.Sc.) programme at SRH University, you will develop essential skills to thrive in the international medical technology industry. You will gain comprehensive knowledge of medical device regulations, including the approval processes for medical devices and health technology products both nationally and internationally, particularly focusing on the European Medical Device Regulation (MDR) and FDA Approval. The program covers key areas such as quality management systems, international approval processes, risk management, post-market surveillance, and the application of artificial intelligence (AI) in regulatory affairs. You will also explore current medical technology trends, ethical considerations, and strategic regulatory processes.
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Regulatory Affairs is far more than just bureaucracy – it is the key to a successful market launch! Modern Regulatory Affairs Managers are evolving into strategic advisors for management. In the Regulatory Affairs (M.Sc.) programme at SRH University, you will develop essential skills to thrive in the international medical technology industry. You will gain comprehensive knowledge of medical device regulations, including the approval processes for medical devices and health technology products both nationally and internationally, particularly focusing on the European Medical Device Regulation (MDR) and FDA Approval. The program covers key areas such as quality management systems, international approval processes, risk management, post-market surveillance, and the application of artificial intelligence (AI) in regulatory affairs. You will also explore current medical technology trends, ethical considerations, and strategic regulatory processes.

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Subjects / Topic Areas

Regulatory Affairs

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Frequently Asked Questions

Quick answers about Regulatory Affairs – Medical Devices Master at SRH University

Is Regulatory Affairs – Medical Devices Master at SRH University taught in German or English?

This Master programme is taught in English. Make sure to check the language requirements (e.g. TestDaF, DSH, IELTS or TOEFL) before applying.

How much does the Regulatory Affairs – Medical Devices Master programme cost?

4.900 EUR / semester. International students should also budget around 800–1000 EUR/month for living costs in Germany.

What are the admission requirements for Regulatory Affairs – Medical Devices Master at SRH University?

Typical requirements include: a recognised secondary/undergraduate degree, proof of language proficiency (English), and (for non-EU applicants) a uni-assist application plus financial proof (Sperrkonto ~11.904 EUR/year).

When is the application deadline?

Application deadlines vary: winter semester usually closes on 15 July, summer semester on 15 January. Always confirm the exact deadline on the official university website.

Can I work in Germany while studying Regulatory Affairs – Medical Devices Master?

Yes. International students may work up to 140 full days / 280 half days per year without additional permission. After graduation you can apply for an 18-month job-seeker permit.

How do I apply to SRH University — directly or via uni-assist?

Most German universities accept international applications through uni-assist for document verification. Some unis accept direct applications — check the programme page on the official site.

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