For medical device manufacturers aiming to access the European market, complying with evolving regulations is essential to ensure patient safety, maintain quality standards, and stay competitive. With growing demands for transparency and patient safety, the European...
Manufacturing
Introduction to SAE J2450: Why Accurate Translation Is Important in the Automotive Industry
The SAE J2450 is a translation quality metric standard within the automotive industry, designed to ensure the accuracy and consistency of multilingual technical documentation. This metric establishes clear guidelines for identifying and categorizing translation...
FDA Translation Requirements: Your Essential Guide to Regulatory Success in US Markets
Ever had that sinking feeling when months of hard work hit a roadblock? That's exactly what happens when companies hear: "Your FDA submission is on hold due to translation issues." We've seen it firsthand. A promising medical device, a breakthrough drug, or an...