ULG’s Language Solutions Blog

Everything ISO Covers That You Weren’t Aware Of

Posted by Kenzie Shofner on June 11, 2019
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

Posted by Kenzie Shofner on April 17, 2019
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?"

Posted by Kenzie Shofner on March 26, 2019
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?

Posted by Kenzie Shofner on February 12, 2019
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

Posted by Jake Schild on January 7, 2019
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

Posted by Jake Schild on January 2, 2019
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

Posted by Jake Schild on October 17, 2018
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

Posted by Jake Schild on October 9, 2018
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

Posted by Jake Schild on August 7, 2018
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?

Posted by Jake Schild on July 11, 2018
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

Posted by Jake Schild on June 20, 2018
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

Posted by jason on April 24, 2018
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