ULG’s Language Solutions Blog

The EU’s New Medical Device Regulation: What’s Language Got To Do With It?

The European Union’s new Medical Device Regulation (MDR) will begin being enforced in 2020. It seems like a long way off, but it will be here sooner than we think. The regulation, which represents a s...

Clinical Trials: An Introduction To The ICH E6(R2) Addendum

  Scientific and medical advances are often dependent on the results of research involving human subjects. This research requires significant ethical and safety considerations, and clinical trials inv...

MDR and Device Labeling: Annex I and UDI Requirements

  On May 5, 2017, the European Commission released the new Europe (EU) Medical Device Regulations (MDR) in an effort to create a more unified and transparent system for medical devices. The MDR will b...

Global Clinical Trials: Saving Time And Money Through Centralization

With the resurgence of dangerous diseases such as whooping cough, malaria, and cholera, the need for clinical trials spanning the globe is stronger than ever. Diseases affect people differently depend...

3 Ways to Ensure Compliance with New EU Medical Device Regulations

  The final versions of the European Union’s new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were published in May of 2017, representing major changes to the EU’s medical...

The Meaning Of Medicine: Translating Drug Names

  The misuse of prescribed medication can lead to serious health problems. Policy makers in the United States are working to implement legislation that will help put an end to the ongoing opioid crisi...

New EU Medical Device Regulations: A Summary of the MDR and IVDR

  The Regulation on Medical Devices (MDR) and the Regulation on in-vitro Diagnostic Medical Devices (IVDR) went into effect in May of 2017, effectively replacing decades-old legislation and creating n...

Leveraging Translation Memories In Clinical Trial Translations

  Anyone who’s completed a major translation project knows that it can be a costly, time-consuming process. But those with experience in the language world also know there are ways to streamline workf...

Cost, Quality and Timelines: Translating Clinical Trials

As clinical trials have emerged in the global marketplace, Pharmaceutical Organizations and Contract Research Organizations (CROs) need to be more cognizant of the challenges that can come with transl...

E-Learning and the Medical Device Industry

      In the medical device industry, regulation is a big deal. Proper training for internal operations staff, and consumer and professional end users, needs to be done effectively in order to ensure ...

Navigating E.U. E-Labeling Regulations

  Electronic Labeling (e-labeling) has the potential to be hugely beneficial to medical device companies creating Instructions For Use (IFU), labels and packaging information. But at the same time, th...

Translating Global Internal Investigation Materials

      It seems like every time I read the Wall Street Journal, I see those four dirty words that make global corporations cringe: Foreign Corrupt Practices Act (FCPA). According to The FCPA Blog, 87 c...