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Whitepaper
Medical Devices
Developing and Maintaining a Quality Management System for IVDs
This paper primarily examines the QMS requirements in the new In Vitro Diagnostic Device Regulation (IVDR) 2017/7462.
Article 10 (8) of the IVDR establishes a number of requirements.
This paper primarily examines the QMS requirements
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QMS Basics
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Strategy for regulatory compliance
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Risk management
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Performance evaluation and postmarket surveillance
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Unique Device Identification (UDI)
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Continuous improvement activities
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