معلومات المقرر

Lehrinhalte
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[*]Introduction
[*]Quality management system according to ISO 13485
[*]Processes according to the quality management system
[*]Development Processes
[*]Verification and Validation
[*]Requirements of the MDR
[*]Classification and placing medical products on the market
[*]Risk Management
[*]Clinical evaluation and investigation
[*]Post-market surveillance
[*]The system of notified bodies
[*]Audits
[*]Usability Engineering
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Literature
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[*]2017/745/EU Medical Device Regulation
[*]ISO 13485: 2016 – Medical devices – Quality management systems – Requiremenst for Stand: 12.03.2020 Seite 2 regulatory purposes
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Voraussetzungen
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