Translation of medical device manuals: operating manuals, IFU and technical documentation

A medical device manual is the document a nurse opens on night duty when an infusion pump raises an alarm, and the one an engineer reads when calibrating a tomograph. In both cases an ambiguity in the translation directly concerns patient safety. That is why medical device documentation stands at the intersection of medical and technical translation: the translator must understand at the same time the clinical context, the engineering terminology and the regulatory framework that defines the form of the manual. We translate medical device documentation for importers, distributors, clinics and manufacturers.

What documents are involved

• Instructions for use (IFU): the manufacturer's official document describing the intended use, contraindications, warnings and method of use of the device
• Operator manual: a detailed description of the interface, modes and alarm system intended for medical staff
• Service and maintenance manual: for engineers, with calibration, preventive maintenance and repair procedures
• Technical passport and specification: parameters, compliance with standards, electrical safety class
• Quick start guide and wall posters for operating theatres and intensive care
• Software interface text: menus, alarm messages, screen text for localisation
• Registration documents: declaration of conformity, CE certificate, FDA 510(k) letter, ISO 13485 certificate, free sale certificate
• Labels and packaging: symbols, storage and transport conditions, sterility markings
• Tender technical specifications for clinics and procurement departments

Which devices we work on

• imaging systems: MRI, CT, X-ray, ultrasound machines, mammography units
• laboratory analysers: haematology, biochemistry, immunology, PCR systems
• vital signs monitoring: patient monitors, pulse oximeters, ECG machines
• ventilators, anaesthesia workstations, infusion and syringe pumps
• surgical and endoscopic equipment, laser and electrosurgical systems
• sterilisation equipment, autoclaves, washer-disinfectors
• dental, ophthalmological and physiotherapy equipment
• home-use medical devices: glucometers, blood pressure monitors, inhalers, CPAP machines

Why medical device translation is a separate discipline

Safety wording

In a medical device manual the signal words (warning, caution, note) are used in a strict hierarchy and each denotes a specific level of risk. In the translation this hierarchy must remain unchanged: "Warning" must always be translated with the same one Georgian word, which is clearly distinct from the equivalent of "Caution". The wording of contraindications, intended use and the expected clinical benefit is also strictly standardised, and the regulator compares it with the original.

Three terminological layers in one document

In one manual three professional languages coexist at the same time: clinical (indications, the patient's condition, the procedure), engineering (electrical parameters, mechanical components, software logic) and regulatory (references to standards, declarations of conformity). Our translators know all three layers, and on complex projects a medical and a technical specialist work together.

Symbols and standards

The symbols used on a medical device label and in the manual are defined by the ISO 15223-1 standard, and in the translation the symbol stays unchanged while its explanation is carried over with the standard Georgian wording. The electrical safety classification (IEC 60601), the degree of protection (IP code), biocompatibility references (ISO 10993) and sterilisation methods are translated with the established terminology, and the standard number never changes.

Software interface localisation

On the screen of a modern medical device the text has limited space and often has to fit within a few characters. Georgian text is on average 20-30 percent longer than English, so when translating an interface we set a length limit for every string and agree abbreviations with the manufacturer. Alarm messages are translated so that a nurse understands at a glance what has happened and what to do. The terminology of the interface and of the manual must match exactly, because the manual quotes the screen text directly.

Regulatory requirements in Georgia

To bring a medical device onto the Georgian market the importer is required to provide Georgian-language instructions for use, and the registration procedure provides for the translation of the conformity documents. For home-use devices the manual must be written in language the consumer understands, and for professional equipment in the language of medical staff. We know which document is required in which format and prepare the package so that registration and customs clearance go through without remarks. Where needed we certify the translation with the agency's seal or notarize it.

Format and the technical side

Medical device manuals are often hundreds of pages, with diagrams, tables and illustrations. We work in InDesign, FrameMaker, XML and Word formats, preserve the layout of the original, translate the captions of illustrations and keep the page numbering and cross-references consistent with the original. Translation memory stores the text repeated between one manufacturer's models, which makes the translation of a new model's manual faster and keeps the terminology uniform across the whole portfolio.

Who contacts us

• importers and distributors of medical devices who need a Georgian-language IFU for registration and sale
• clinics and hospitals implementing new equipment and requesting a translation of the operator manual for their staff
• tender commissions and procurement departments that need to compare technical specifications
• foreign manufacturers entering the Georgian market and entrusting the localisation of their documentation to one partner
• laboratories and diagnostic centres for the service documentation of analysers

Medical device documentation often comes together with pharmaceutical and clinical documents, so we cover all the medical services with one terminology base, as described on the main medical translation page.

Frequently asked questions