Effects of Official Regulations on Medical Technology Documentation

Current Guidelines and Regulations for Medical Technology

In late 2012, the EU Commission and the European Parliament proposed a new Medical Devices Regulation (MDR) that is currently in thefinal approval process. This new text explicitly requires multilingual,
comprehensible documentation, making it necessary for many medical technology companies to restructure their previous editorial processes and consider the subject of translation and translation management. This white paper summarizes the changes and shows how businesses can tune their processes to the future regulations.

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Information Security in Translation Processes

Enterprises do a lot to protect the data on their servers. For example, they implement backup routines, firewalls, as well as declared processes and sets of rules. However, as soon as documents are sent to external service providers for translation and leave the company, information security is no longer guaranteed unless suitable measures are taken. The associated risk is often underestimated. This white paper describes how enterprises can protect information from manipulation, theft, loss, and unwanted disclosure to unauthorized parties.

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