ULG’s Language Solutions Blog

Everything ISO Covers That You Weren’t Aware Of

Since 1947, the International Organization for Standardization (ISO) has been creating quality control standards to ensure the safety of products and services worldwide. With more than 22,000 quality standards in industries ranging from healthcare to food and ...

Topics: Featured, Localization, Strategy, Tips & Tricks, Translation, Compliance


Conference Connections: ULG to attend European UDI Forum

Eileen Kerry, out of ULG’s Galway Office, will represent ULG at this forum, exploring current and future regulations for how medical devices are labeled. This is the only European conference dedicated to global UDI compliance and wider industry implications. ...

Topics: healthcare, Compliance, MDR


GDPR Enforcement: Are you prepared for an audit or a "dawn raid?"

It’s nearly the one-year mark for the Global Data Protection Regulation (GDPR) and we’re starting to see enforcement already. Most notably, of course, is the $57 million fine to Google for violations. Even companies who are very stringent about data privacy ...

Topics: Featured, Strategy, Technology, Compliance, GDPR


Understanding the Medical Device Regulation: What is a Notified Body and What Function Does it Serve?

Almost two years after its initial publication, many medical device companies are still in the process of adapting to the new EU Medical Device Regulation (MDR). Although this regulation was released in May 2017, the transition process will last through 2020 ...

Topics: Featured, Localization, Strategy, Tips & Tricks, Translation, Compliance, MDR


21 CFR Part 11: Helping Med Device Companies Abide by the FDA’s Electronic Records Regulation

With the medical industry constantly expanding and sharing knowledge and products worldwide, having a physical file room to house all paperwork and records is no longer a viable option. Medical device manufacturers and pharmaceutical companies usually ...

Topics: Featured, Localization, Strategy, Translation, Compliance


New Roles of Economic Operators Under the MDR

When the European Union passed the Medical Device Regulation (MDR) back in April 2017, economic operators involved in the importation and distribution of medical devices became subject to new regulatory changes that would affect their ability to conduct ...

Topics: Featured, Localization, Strategy, Translation, Compliance, MDR


Why a Secure Translation Workflow is Necessary

The bulk of translation projects are conducted on computers and through the Internet. The client must transfer the original document and any supplementary materials to the translator at the start of the project, and the translator will need to transfer ...

Topics: Featured, Strategy, Compliance


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 choose to follow ISO standards to foster trust with ...

Topics: Featured, Strategy, Compliance


Regulating Big Data: SC 42 and Artificial Intelligence

According to the International Data Corporation (IDC), 40% of digital transformation initiatives will use Artificial Intelligence (AI) services by 2019 and 75% of enterprise applications will use AI by 2021. The IDC also estimates that spending for AI ...

Topics: Featured, Technology, Translation, Compliance


Why is ISO 13485 Important in the Language Industry?

Since 1947, the International Organization for Standardization (ISO) has created thousands of quality control parameters for a variety of industries to ensure that global companies produce the safest consumer goods, including food, medicine, and vehicles. ...

Topics: Featured, Localization, Translation, Compliance


Webinar Recap: Language-Specific Requirements of the MDR

Last week ULG hosted a webinar on the language-specific requirements of the European Union’s new Medical Device Regulation (MDR). Renowned MDR expert, Ronald Boumans, discussed key language-specific areas that global organizations must be aware of to ensure ...

Topics: Featured, Localization, Translation, Compliance, MDR


Securing Patient Data: What Your Language Provider Should Know About HIPAA

By jason
While HIPAA compliance might complicate your life, the goal of the regulation is really the same as yours: protecting patients. You’re looking out for their physical well-being, while HIPAA is safeguarding their private information. Medical professionals ...

Topics: healthcare, Translation, Compliance, Compiance, HIPAA, Language Providers, Legal