ULG’s Language Solutions Blog

Questions and Answers About the Summary of Safety and Clinical Performance Guidelines

In the third and final webinar of the series with Ronald Boumans, senior consultant for regulatory affairs at Emergo by UL we learned on the importance of Summary of Safety and Clinical Performance (S...

Navigating MDR: Article 59 – CE Derogation

If you are anything like us, you’ve experienced steady changes with the continuously evolving MDR requirements. In 2020, the new European Medical Device Regulation (MDR) was rolled out. These guidelin...

The Perfect Label—Complying with the MDR

European Medical Device Regulation (MDR) is continuously evolving, making it difficult to keep up with all of its requirements. It is important to understand these guidelines to ensure that your medic...

European Union MDR: What’s Language Got to Do with It?

It has now been a year since the European Union’s new Medical Device Regulation (MDR) enforcement. It may seem like a long time ago, but there is still work to be done and regulations to understand so...

A Beginner's Guide to ISO Identification of Medicinal Products

The International Organization for Standardization (ISO) is the world’s leading quality control organization that sets standards related to manufacturing, product labeling, and safety. Many companies ...

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...

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