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In this module you will learn about how to identify the regulatory needs of working together with Austrian companies and public organisations; how to know whether your product need to comply with these guidelines and how to apply for certification marks.

 

Topics:

– What is digital health?
– What is GDPR?
– What are the main features of regulating digital health?
– What are the main challeges applying regulatory guidelines to digital health?
– What is a medical device?
– What types of medical device are there?
– What guidelines apply in Austria?
– Is a software a medical device?
– What are the risk classes of medical device categories?
– Is my software a medical device? – What works and what doesn´t
– Conformitè Europëenne Mark (CE Mark)
– What are the main differences between CE Mark and FDA    approval?

Hi my name is Eszter Korman, I am the Operations Manager at Health Hub Vienna.

Start our course by pressing the button down below. When you have finished the video please mark the course as completed to get your certificate.

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