Technical
Deep clinical knowledge in medical technologies, combining hands-on radiologist experience with technical translation expertise to ensure accurate documentation for regulatory submissions and user materials.
Instructions for Use (IFU)
Expert translation of Instructions for Use for in vitro diagnostic (IVD) devices, MRI and CT systems, ultrasound scanners, and other medical equipment, using MDR/IVDR-compliant terminology and formatting.
Labelling and Packaging
Accurate translation of device labelling, packaging content, and UDI-related fields, aligned with EU regulatory and terminology standards for clarity and compliance.
Software and Digital Interfaces
Translation of software documentation, user interfaces, and app/web copy for connected devices, health wearables, and diagnostic platforms, ensuring linguistic precision and regulatory consistency.
Software & Digital Health
Translation of user interfaces, software manuals, and app/web content for digital health platforms, wearable devices, and medical software. Emphasis on clinical accuracy, linguistic clarity, and alignment with regulatory terminology.
Innovation-Focused & Specialised Equipment
Translation of documentation for next-generation technologies, including AI-assisted tools and devices, combining scientific rigour with usability for technical audiences.
Expert translation of documentation, including technical specifications, operation manuals, safety protocols, hardware specifications, contrast protocols, safety guidelines and clinical applications for diagnostic imaging equipment.
Specialised translation for magnetic resonance imaging equipment, covering hardware specifications, contrast protocols, and safety guidelines.
Translation services for ultrasound systems and echocardiography equipment, including technical manuals and diagnostic procedure documentation.
Expertise in gamma cameras, PET scanners, and PET-CT hybrid systems, translating complex technical and clinical documentation with precision.
Technical translation for elastography systems used in tissue stiffness assessment, including ultrasound-based and MRI-based elastography documentation.
Comprehensive translation services for the full spectrum of in vitro diagnostic devices, from research-use products to companion diagnostics, ensuring regulatory compliance and clinical accuracy.
Translation of documentation for laboratory research products not intended for clinical diagnostic use, maintaining scientific precision.
Specialised translation for investigational diagnostic products under clinical evaluation, ensuring protocol compliance and regulatory accuracy.
Expert translation of ASR documentation, including performance characteristics, intended use statements, and regulatory labelling requirements.
Translation services for laboratory-developed test protocols, validation documents, and quality control procedures for in-house diagnostics.
Precise translation of companion diagnostic IVD materials, ensuring alignment with clinical trial data and regulatory submissions.
Medical devices span a wide range of technologies beyond imaging and IVDs, each with its own regulatory, linguistic, and usability demands. This section outlines key categories and the critical documentation that typically requires precise, domain-specific translation to meet MDR/IVDR and market-access requirements.
| Medical Device Category | Examples of Medical Devices | Critical Documentation Requiring Translation |
|---|---|---|
| Active Therapeutic & Life Support Devices (Devices that administer energy or substances for treatment, or sustain life) | Infusion pumps, Ventilators (lung ventilators), Defibrillators (Automated External Defibrillators – AEDs), Hemodialysis machines, Surgical lasers, Electrosurgical generators, Analgesia pumps, Hyperbaric chambers. | Instructions for Use (IFU), User Interfaces (Software Localization), Regulatory Submissions (Technical Files, Risk Management Documentation), Service and Maintenance Manuals |
| Monitoring & Measurement Devices (Non-imaging devices used to track physiological status) | Non-invasive blood pressure monitors, Electronic thermometers, Pulse oximeters, Cardiac monitors, Holter monitors (for continuous surveillance of vital physiological processes), Manual stethoscopes. | Labelling and Warning Messages, Software and Display Localization, Clinical Data (e.g., reports supporting claims). |
| Invasive Surgical Instruments & Implants (Devices penetrating the body through surgery or natural orifice, including long-term devices) | Transient/Short-Term: Needles and syringes, Surgical gloves (sterile or non-sterile), Scalpels/Non-powered surgical instruments. Implants/Long-Term: Cardiovascular catheters, Stents (e.g., cardiovascular), Orthopaedic implants (e.g. hip or knee replacement implants), Pacemakers/Neurostimulators. | Clinical Evaluation Reports (CER), Instructions for Reprocessing (for reusable devices, Class Ir), Patient Implant Cards, Sterilization Instructions (Class Is devices), Detailed Surgical Protocols. |
| Channelling, Storage, and Manipulation (Devices handling substances intended to enter or return to the body) | Blood bags (containing anticoagulant/preservatives), Administration sets for infusion/tubing, Urine collection bags with graduated scale (measuring function), Storage containers for organs/tissues. | Technical Documentation (e.g., Material Safety Data Sheets), Labeling (compliance with UDI requirements for Class II/III). |
| Assistive Technology & Supportive Devices (Products providing compensation for disability or general external support | Wheelchairs, Walking aids (canes, crutches), Hearing aids, Dental aligners/retainers, Hospital beds, Bandages/Wound dressings (mechanical barrier/compression). | User Manuals (clarity and patient comprehension are vital for safe use in home care), Product Information for Reimbursement (if applicable), Editing & Proofreading (monolingual polish for clarity). |
Professional translation of marketing materials, product launches, sales documentation, and promotional content for medical device manufacturers.
Professional translation of healthcare marketing materials, medical education content, and communication campaigns for medtech companies.
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