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University of Eastern Finland
Fundamentals of Medical Device Approval Process and Quality Control
Learn the essentials of EU medical device regulation, from development and approval processes to clinical evaluation, vigilance and market requirements. This course helps you find reliable regulatory information and understand the field's key actors in Europe.
From
2 cr
Clinical evaluations and investigations on medical devices, markets and product development from a company perspective. Handling of deviations, incidents, and adverse events (vigilance system) concerning medical devices. Essential rules and regulations related to the medical devices within the EU market area.
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Scope
2 cr
Code
LS00EN31
Organiser
University of Eastern Finland