New Roles of Economic Operators Under the MDR

New Roles of Economic Operators Under the MDR

Economic operators – manufacturers, importers and distributors – in the medical device supply chain must comply with new requirements under the MDR to improve device quality and safety.

Why a Secure Translation Workflow is Necessary

Why a Secure Translation Workflow is Necessary

A secure translation workflow, administered through a Translation Management System (TMS), protects sensitive data related to translation projects through protocols such as secure servers, password protection, and encrypted file transfer.

Regulating Big Data: SC 42 and Artificial Intelligence

Regulating Big Data: SC 42 and Artificial Intelligence

The ISO/IEC JTC 1/SC 42 committee is researching Artificial Intelligence to craft a set of standards to be used globally. Given the extensive use of automation in the language industry, the new regulations will have a big effect on LSPs.

Why is ISO 13485 Important in the Language Industry?

Why is ISO 13485 Important in the Language Industry?

ISO 13485, most recently updated in 2016, provides standards for all organizations involved in the medical devices industry to prevent misuse. Adhering to these stringent quality control standards minimizes risks of injury and helps medical practitioners administer treatment correctly.

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