Localization of IFUs for Medical Devices

Ciklopea’s IFU localization solutions have been developed to meet and exceed the stringent medical industrial demands through combination of professional human knowledge, smart application of the cutting-edge technologies and a highly developed project management.

Instructions for use (IFUs) for medical devices and in-vitro Diagnostic (IVD) medical devices are digital or printed documents that feature detailed information on proper use and maintenance of a wide range of medical devices including software, instruments, apparatuses and more.

IFUs are used by medical doctors, healthcare workers and patients for diagnostic and therapeutic purposes for diagnosis, treatment, monitoring and investigation of diseases, handicaps and other physiological processes.

Regardless of complexity or simplicity of a medical device, accuracy, precision and clarity of IFUs are essential for proper use and this is the reason why translation or localization of these materials is performed by highly experienced multidisciplinary expert teams with linguistic proficiency and medical industry background.

All IFUs at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Translation Asset Management Explained

Quality at Ciklopea

All technology and manufacturing translations produced by Ciklopea are compliant with relevant standards which ensure accuracy and clarity of your materials.

Quality Standards for Which We Are Certified

  • ISO 9001:2008 – Quality Management System
  • ISO 17100:2015 – Quality Management System for Translation Companies
  • ISO 27001:2013 – Information Security Management System