LGC Group
Accelerating US medical device registration through large-scale technical translation
As part of a business transfer from Germany to the United States, LGC Group needed to translate design history documentation for 48 medical devices from German into English. The Translation People provided specialist medical translation and structured localisation workflows to support regulatory submission timelines and maintain continuity across quality and certification processes.
- Medical
Project Manager, LGC
The transfer of our medical device production site was highly successful. The Translation People played a critical role by translating technical documentation for 48 products accurately and within a tight regulatory timeline.
About the client / project
LGC Group is a global life sciences company providing measurement tools, reference materials, genomics services and quality assurance solutions to pharmaceutical, biotechnology and medical device organisations. Their products and services support highly regulated environments, where accurate documentation, traceability and compliance are essential. As part of a strategic business transfer from Germany to the United States, LGC needed to translate design history documentation to maintain certification continuity and support US product registration.
- Medical device technical translation and regulatory documentation transfer
- German to English (United States)
- One-year documentation transfer programme
- Translate design history files for 48 medical devices accurately and on schedule to support regulatory submission, certification continuity and US market access
The challenge
The transfer required the accurate translation of highly detailed design history files covering 48 medical devices. These documents included engineering specifications, validation records, testing documentation and quality management material. Terminology needed to align with regulatory expectations, and consistency across product files was critical. Even minor discrepancies could trigger questions during certification or review.
The scale of the programme added further complexity. Documentation was delivered in phases, often with shifting timelines and evolving priorities. LGC needed a partner able to handle sustained volume without compromising accuracy, while adapting to changes as the transfer progressed.
The translation work also had to integrate seamlessly into an existing regulatory and quality framework. Clear communication, disciplined file handling and predictable turnaround times were essential to keep the wider transfer programme on track.
Medical products transferred and translated
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German → English words translated for US registration
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12-month structured delivery programme
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The solution
The Translation People implemented a structured delivery model designed for regulated medical device documentation. From the outset, the focus was on creating a predictable workflow that could handle sustained volume while maintaining the level of accuracy required for regulatory review.
Specialist medical linguists were assigned based on subject expertise and familiarity with medical device documentation. This ensured technical terminology, validation language and quality management references were translated correctly and consistently across all product files.
Translation memory was introduced early in the programme to capture approved terminology and previously translated content. This kept terminology consistent across product documentation and reduced duplication as the project progressed. Over time, it improved efficiency and helped accelerate delivery.
Clear communication and meticulous file handling also played an important role. The Translation People worked closely with LGC to manage phased deliveries, respond quickly to queries and adapt to changing timelines. This provided LGC with a reliable localisation process that aligned with the wider regulatory transfer programme.
As the partnership developed, the established translation memory and terminology resources also created a foundation for greater automation, with translation technology applied to suitable content while specialist linguists remained responsible for final review and regulatory accuracy.
The results
LGC completed the translation and transfer of design history documentation for 48 medical devices within the planned programme timeline. This supported continuity of certification and allowed US product registration processes to proceed without delay.
Consistency across documentation sets reduced the likelihood of regulatory queries and minimised the need for clarification during review. Structured workflows and translation memory improved efficiency as the programme progressed, particularly as similar technical content appeared across multiple product files.
The transfer programme concluded successfully, contributing to portfolio expansion in the US market and generating positive internal feedback across regulatory and quality teams. Beyond the immediate project, LGC established a localisation framework that can be applied to future regulatory documentation and cross-border transfers.
The experience
For LGC, the experience was defined by The Translation People’s responsiveness, flexibility and clear communication throughout a complex, time-sensitive programme. Documentation was transferred in stages, often with changing priorities and tight turnaround expectations. The account management team remained closely aligned with LGC’s team and responded quickly to queries, adapting to delivery schedules and maintaining steady progress across the full scope of the transfer.
The relationship was described as transparent and straightforward, which was particularly important given the regulatory significance of the documentation. LGC’s stakeholders needed confidence that each stage of the process was handled correctly and that timelines would be met without compromising accuracy. Consistent account management, structured workflows and reliable delivery helped maintain that confidence over the course of the programme.
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