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Meaningful patient engagement through language access

Meaningful patient engagement As the global healthcare industry shifts toward a patient-centric model, patient engagement has become a critical component …

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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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Streamlining Translation of Adverse Event Reports

Those involved in conducting multi-center clinical trials know that managing Adverse Event (AE) reports received from global trial sites can …

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