Technical documentation required by the EU Directives and other regional authority guidelines specifically include provisions for translating Instructions For Use (IFU). As the name suggests, IFU is the description of a medical device’s intended purpose, such as the target patient population and medical conditions, method of use, or if the device is intended for professional use by doctors, physicians, medical practitioners, or patients themselves. Furthermore, IFUs must be kept up to date to capture any information changes during the product’s lifetime.

In terms of translation services, IFUs must be translated accurately to prevent misuse by the intended operators. In addition to technical accuracy, the translated content must be linguistically fluent and regulation compliant. All of these requirements mean the translation vendor must have the experience, regulatory compliance knowledge, and language technology solutions to produce consistent quality results with speed. Stepes is ISO 13485:2016 certified, which is an international quality standard specifically developed for medical devices companies and their suppliers to consistently meet customers’ quality requirements.