Medical Devices


Medical devices are any instruments intended by the manufacturer to be used for human beings for medical purposes. Directive 93/42/EEC classifies them into four groups depending on the risk they may pose to a patient’s safety:

  • Class I: low risk devices such as non-invasive devices.
  • Class IIa and Class IIb: higher risk devices such as invasive devices used in either the long term (IIa) or the short term (IIb).
  • Class III: devices that pose the highest risks and are subject to a rigorous process for pre-market approval, such as devices incorporating a medicinal product.

In addition to this directive, ISO 13485 standard on quality management systems, and ISO 14971 standard on the application of risk management are applicable to these devices.


The technical documentation supplied with medical devices is prepared with absolute rigour and thus its subsequent translation into other languages must be at the level of this industry’s standards. This type of translation requires high precision and a wide range of scientific knowledge. One translation error could not only bring into question the manufacturer’s compliance with the applicable standards, but could even put the health of the patient or user of the device at risk.

Being aware of the major implications this task may have, Bluebird Translations brings into play a wide variety of professional resources and the greatest translation and Quality Assurance tools in order to provide error-free translations of the highest quality.

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