MEDICAL DEVICES MEDICAL DEVICES

Medical devices and healthcare products include instruments, equipment, implants, materials, etc. used to diagnose, prevent and treat disease in human beings. They are also used for other purposes, such as contraception. These products are subject to strict regulations that can vary depending on the country where the product is sold. Medical devices are classified into the following groups:

  • Class I: devices with a very low risk factor.
  • Class II: devices with a moderate risk factor.
  • Class III: devices with a high potential risk factor.
  • Class IV: devices that are considered to be the highest risk.

The greater the risk factor and invasiveness, the more crucial it is that the translation is correct. There is no room for error. All related texts, such as IFUs (instructions for use), user manuals, labelling, software, catalogues and brochures must be faithful to the original, accurate and precise. That is why our linguists are technical specialists of proven expertise and the exhaustive checking process demanded by standard ISO 17100 further guarantees error-free translations with no inconsistencies or inaccuracies.

Our biggest medical device clients include manufacturers of: eye surgery equipment, ultrasound scanners, external defibrillators, orthopaedic implants, orthopaedic surgery prosthetics, dental implants, cosmetic surgery instruments, medical imaging, surgical sutures and gauzes, electromedical equipment, electrostimulators for physiotherapy, oral health products, in vitro diagnostic systems, intrauterine devices, non-invasive monitoring equipment, etc.

MEDICAL DEVICES DOCUMENTS

• IFUs (Instructions for Use)
• Packaging
• Labelling
• Brochures
• Instruction manuals

• Quick user guides
• Stability studies
• Technical dossiers
• Product catalogues
• Leaflets and web content

• Informed consents for
clinical trials
• Protocol reports for clinical research
• Software localisation for
medical devices

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