Medical Devices & Diagnostics Translation
Regulation aware translations for medical device documentation, labelling and instructions for use.
We support medical device manufacturers, distributors and notified bodies with accurate, compliant translations.
Medical device content sits at the intersection of engineering, medicine and regulation. Instructions for use, packaging texts, software interfaces and clinical evaluation documents must be accurate and fully aligned with regulatory expectations. Our translators work with IFUs, labels, user manuals, risk management files and submission documentation across many device classes. They understand terminology used in MDR, IVDR and other regulatory frameworks and are used to working with controlled language and strict change control. This helps manufacturers reduce risk, improve user safety and streamline approvals in multiple markets.
Medical Devices.
- Instructions for use and quick reference guides
- Device labels, packaging and carton text
- Risk management and vigilance documentation
- Clinical evaluation and performance reports
- Regulatory and technical documentation
- Software UI strings for diagnostic equipment
Medical Devices
- Handling strict regulatory terminology (FDA, EU MDR etc.).
- Translating IFUs while preserving technical precision.
- Ensuring patient safety through clear language.
- Managing version control across device updates.
Medical Devices
Medical Devices?
Medical Devices.
Medical Devices.
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IFU localisation for new monitors -
Software interface for diagnostics