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In-Virto Device Regulation

Ready or Not – Here comes IVDR

The European Union’s new regulation for in-vitro medical devices, 2017/746 (IVDR), takes effect in May 2022. While IVDR aims to …

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The Race to EU/MDR Compliance

The passing of Brexit in early 2020. The ongoing monitoring of candidate countries. COVID-19. Three formidable challenges have all complicated …

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ISO 13485 and the new EU MDR 2017/745

The use of international standards to ensure consistent high-quality goods and services has long been an accepted practice. In a recent …

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How to Prepare for Europe’s Medical Device Regulation 2017/745 (EU MDR): Localization Tips and Best Practices

The new European Union Medical Device Regulation (MDR 2017/745) brings significant changes to previous regulations. Device manufacturers who market products in the …

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