Global Life Sciences Regulatory Environment
The life sciences industry Life sciences (medical devices, pharmaceutical, biotech) have some of the most stringent regulatory landscapes in the …
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Posts with tags: Compliance Training, Learning, Life Sciences, Training
Terminology Management for Life Sciences
Glossaries and Termbases for Medical Device Companies As social, political, and economic ideologies shift and evolve throughout the world, so …
Software Localization for the Life Sciences Industry
Software Localization Impacts The User Experience Life sciences software localization requires much more than simply checking off a list of …
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 …
Healthcare Industry Translation Experts-Meaningful Patient Engagement
Meaningful Patient Engagement Accurate translations in the healthcare industry are more critical than ever for patient engagement. Patient engagement has …
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 …
ISO 13485:2016 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 …
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 …
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 …
