Translating for medical devices
Medical-device translation combines clinical, technical and software content with the requirements of each market and the manufacturer's supply chain.
Documents and clients
Device translation covers software, packaging, user manuals, marketing materials, technical specifications, engineering drawings, labels, instructions for use, distributor information, legal matters, clinical trial texts, training materials for e-learning and instructor-led courses, implementation information, websites and app content. These texts have varied authors, readers and writing styles.
Clients include manufacturers, distributors and other interested parties. Buyers range from small companies using individual freelancers for a single language pair to global manufacturers spending millions a year on programmes managed in-house or through one or more large language service providers.
Market requirements
Device imports and distribution are subject to strict approval processes and compliance measures intended to protect patients and businesses from risk. Internationally recognised systems meet many compliance needs, but no single system applies universally, and differing national requirements mean generic guidelines cannot be relied on for a particular market.
Linguists and domain knowledge
The translation team needs to understand the device, its use and the regulations of its target markets. Medical expert linguists, ideally with a life sciences background, are central to the work, but medical knowledge alone may not meet a manufacturer's needs. Device linguists also need strong knowledge of the specific domain and an understanding of how devices differ from small molecules and biologics. Software localisation may require clinical understanding alongside software skills, while engineering drawings and technical specifications call for expertise beyond general medical knowledge. A translator with a technical or engineering background may therefore be an advantage for device texts.
Supplier audits
Device supply chain audits can demand more extensive compliance measures from language service providers than most other clients require. Many translation buyers audit providers against ISO 13485:2016, the medical-device quality management standard, insofar as it applies to service providers, with reference also made to ISO 14971 on device risk management. Providers can be audited against the relevant systems to the extent that they apply to service providers. Certification to a device quality management system such as ISO 13485:2016 gives many manufacturers additional confidence in a translation company.
Processes and information systems
A device translation provider's work goes beyond the usual localisation basics and contributes to successful regulatory submissions. Fluid processes can help regulatory approval and speed to market. Aligning the manufacturer's content management system with the translation management system can support integration with regulators' databases and smooth data flow.
Providers should help manufacturers improve beyond a quality baseline by identifying inconsistencies, understanding regulations and knowing the purpose of each document or software string. Providers and manufacturers should form partnerships to develop their work together in serving patients and device stakeholders. Device work requires special workflows, domain expertise and linguistic talent supported by additional quality assurance.
Plain language for intended users
As described in March 2024, the EU Medical Device Regulation required information given to the subject to be comprehensive, concise, clear, relevant and understandable, and referred to the intended user. What a healthcare professional can easily understand often differs from what a patient can easily understand. Depending on how far the original text departs from the target audience's expectations, translation may require extensive rewriting, shortening or restructuring. Linguists therefore need to know what plain language means in the target locale, which limits the pool of suitable linguists.