Web-Portal Solution for Supporting In-Country Reviews

摘要

As a leading language service provider to the Healthcare industry for many years, nlg GmbH has observed the needs and identified problems of Healthcare clients in regards to the mandatory and regulated in-country review of translated content. In Europe, Directives such as the Medical Device Directive (MDD) 93/42/EEC describe the localization requirements for Instructions for Use as well as Safety and Warning information for Medical Devices. Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users. If documentation is translated into the required language of the importing country, the manufacturer should have procedures to ensure the accuracy of translated content in connection with the source language. This requirement is usually met through an in-country review process. It is a necessary quality assurance step before final product approval in a foreign country.