Annual course fee
AUD 16,000
Duration
2 Years
Intake months
April, october
Delivery locations
Fürth
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.
Type of institution
University
Year established
2002
On campus accommodation
Not Available
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