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May 2024

A Guide to Process Validation - Smooth Sailing, not Stormy Seas
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April 2024

The Equivalence of Medical Devices Under MDR: A Guide
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Harmonizing Vigilance Reporting: A Guide to the MDCG's Device Specific Vigilance Guidances (DSVGs)
April 2024

Harmonizing Vigilance Reporting: A Guide to the MDCG's Device Specific Vigilance Guidances (DSVGs)
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March 2024

EU Proposal for IVDR and MDR: Step-by-Step Implementation of EUDAMED, Prior Notice Obligation for Supply Interruptions, and Transitional Arrangements for Certain In Vitro Diagnostic Devices
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March 2024

Is your quality management ready for the US market? Adaptation of 21 CFR Part 820 to ISO 13485: From QSR to QMSR
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February 2024

Post-Market Surveillance Data in Clinical Evaluation - and the Correct Sequence
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January 2024

Customized Medicine - Custom-Made Devices under the Medical Device Regulation (MDR)
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January 2024

Regulatory Affairs Trends 2024 – Insights and Perspectives in Medical Technology
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December 2023

Biological Evaluation from the Perspective of Clinical Evaluation According to the MDR
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December 2023

The cooperative interplay between risk management and usability in medical devices
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November 2023

Post-Market Surveillance International: USA and Canada
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November 2023

Clinical Evaluation of Medical Devices: A Guide for Beginners
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