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Medical device software regulation

 Steve Eglem
Description: Medical device means any instrument, apparatus, appliance, software, material or another article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application.
Views: 902
Domain: Medical
Category: Implants
Contributing Organization: VUB TechTransfer
 ‐ More of their Presentations
Maxims of Tech: Rules of Engagement for a Fast Changing Environment
Regulation of software a medical

Steve Eglem
Responsible of clinical investigation @ famhp
Member of the medical device European Clinical
and Evaluation (CIE) working group

Famhp presentation
European and Belgian legal framework on medical
• Legal reference
• Definitions & Examples
• Classification
• Software as medical device
... See more

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