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Published
(Updated )
Metropolia University of Applied Sciences
Regulations and Standards for Medical Devices
Learn to understand the legislative requirements for medical devices and how to meet them in order to place medical devices on the market, taking into account clinical evaluation and investigation, usability, risk and quality management, and cybersecurity.
5 cr
EU and FDA medical device regulations
Regulatory path for medical devices, from defining the intended purpose to post-market activities
Clinical evaluation and investigation
Standards and guidance related to risk, quality, usability, and cybersecurity
Case study on a selected medical device
Contains
Check the institution’s website for the required studies.
No active implementations at present.
Additional information and registration
- Price and registration period
Check on the university's website
Additional information:
Scope
5 cr
Code
IT00GO61
Organiser
Metropolia University of Applied Sciences
Contact details
avoinamk@metropolia.fi