High-Precision Medical Device Translation for European Market Launch

Axis Biomedical needed flawless, EU MDR-compliant translations of technical files to launch its new BioScan 5000 device in four languages. Our expert medical translators, rigorous quality assurance, and advanced technology ensured full compliance and a successful, on-time market entry.

Client: Axis Biomedical

Industry: Medical Device Manufacturing

Services Provided: Technical Translation (Instructions for Use, EU MDR Documentation, Packaging & Labelling)

The Case Study Covers

• The critical challenges of a multi-market medical device launch
• The specialist solutions Translations.co.uk provided for regulatory success
• The outstanding results achieved for our client, Axis Biomedical

“The quality assurance process at Translations.co.uk is second to none. They delivered technically perfect translations that sailed through compliance checks. They are true experts in their field.” – Axis Biomedical

Client Background

Axis Biomedical is a cutting-edge medical device manufacturer specialising in innovative portable diagnostic technologies. To drive international growth, the company planned a pan-European launch for its latest device, the BioScan 5000. This required technically precise and regulatorily compliant translations of all supporting documentation to ensure market approval and user safety.

Challenges

• Absolute accuracy was critical for patient safety and device efficacy.
• Strict compliance with the EU Medical Device Regulation (EU MDR) was mandatory.
• Highly complex scientific and engineering terminology requires specialist knowledge.
• Maintaining formatting across Instructions for Use (IFUs) and packaging was essential.
• A tight, coordinated deadline had to be met for a simultaneous launch in four countries.

Solutions

• Assembled a dedicated team of ISO 17100-certified medical translators.
• Created a central Terminology Base (TermBase) to guarantee consistency.
• Implemented a multi-step quality assurance process, including Subject-Matter Expert review.
• Utilised Desktop Publishing (DTP) services to work directly within original file formats.
• Coordinated all workflows to deliver four language projects simultaneously.

Results

We successfully delivered fully compliant technical translations for Germany, France, Spain, and Italy on schedule. The documentation met all EU MDR and ISO 13485 standards, leading to swift regulatory approval with no revisions required. Axis Biomedical praised our technical expertise and project management, which enabled them to launch the BioScan 5000 successfully and confidently across Europe. This has resulted in a long-term partnership for ongoing translation needs.