Where translations originate from uncontrolled sources — for example, content produced by non-professional linguists or automated tools — revision alone does not recreate full ISO 17100 compliance. In such cases, we provide transparent guidance on the status of the work so that manufacturers can assess suitability within their own quality systems and maintain traceability of outsourced activities.
Our work typically involves materials that directly influence safe use of a device, including instructions for use (IFUs), patient information leaflets (PILs), packaging artwork, safety inserts, product labelling and consumer-facing guidance. Errors or inconsistencies in these materials can lead to misuse, regulatory non-conformities or product withdrawals, particularly when devices are distributed across multiple jurisdictions with differing language requirements.
Manufacturers supplying consumer channels or e-commerce platforms face additional challenges. Packaging space is limited, text often appears in multiple languages simultaneously, and updates may be issued as small fragments rather than complete documents. Patient-facing materials such as PILs are frequently revised independently of core technical documentation, requiring careful version control. We regularly work from partial source material, artwork extracts or spreadsheet-based text lists while maintaining consistency with approved terminology and existing documentation.
Our processes support:
- Traceability of revisions and versions across product lifecycles
- Consistent terminology across device families and variants
- Independent review by qualified specialists
- Secure handling of confidential technical information
- Clear documentation of translation provenance
- Alignment with existing manuals, labelling, PILs and regulatory submissions
This enables manufacturers to incorporate multilingual content confidently into their ISO 13485:2016 frameworks while retaining full oversight of outsourced processes.
