Tag: regulatory translation

mdr language translation

Introduction The European Union Medical Device Regulation (MDR) adopted in April 2017, changed the European legal framework for medical devices and introduced new principal and supportive responsibilities for EMA and for national authorities in the assessment of certain categories of medical products. The aim of the MDR is to ensure patient safety and provide greater transparency and traceability … Learn More

IVDR Translation Process

Introduction EU Regulation 2017/746 is a regulation enacted in 2017 for releasing in-vitro medical devices into the European Union.  It was published in April ’17 and is closely aligned to the EU regulation on medical devices. The IVDR has a significant impact on Medical Devices companies from a language translation perspective, as they initiate clinical … Learn More

Regulatory Translation Icon

What is The GDPR? The General Data Protection Regulation (GDPR) is an EU regulation that sets more stringent rules to improve data protection and privacy for all individuals residing within the European Union. GDPR was approved on 24 May 2016, and gives all organizations until 25 May 2018 to fully comply with the new legislation. Does … Learn More