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  • Annual course fee

    AUD 16,000

  • Duration

    2 Years

  • Intake months

    April, october

  • Delivery locations

    Fürth

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Students from Australia are accepted for this course

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. Only those who understand regulations and their impact on product approval can effectively access the right markets and position products efficiently.

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. You will learn how approval processes for medical devices work on national and international levels and explore the strategies companies use to bring products to market efficiently and in compliance with legal requirements. A key focus is on aligning regulatory frameworks with business objectives, enabling innovation while maximizing market opportunities.

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IELTS 6.5

PTE 59

TOEFL 87

  • Type of institution

    University

  • Year established

    2002

  • On campus accommodation

    Not Available

Campus offering this course
Furth Campus - SRH Berlin University of Applied Sciences - SRH Berlin Universities

SRH University Campus Fürth Merkurstraße 19 90763 Fürth

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