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LBW - IVDR

IVDR – Performance Evaluation

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QM - System

Setup, certification and further development

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Auditing

Execution of external and internal audits

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Clinical Evaluation

For medical devices,
CE-Documentation

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MDR - Transition

Transition to the new
EU - Regulation MDR

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IVDR - Transition

Transition to the new
EU - Regulation 2017/746 (IVDR)

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Riskmanagement

Risk analysis and
Risk assessment

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PMS - Post-Market-Surveillance and Vigilance

PMS - Post-Market-Surveillance and Vigilance

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Technical Documentation

Setup, certification and further development

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Registration

Medical devices, medicinal products
and novel foods

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Validation

Method and process
validation

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