Medical Device Translation for Innovate Med-Tech

NAATI-certified translation of technical medical documents
Translation of EU MDR compliance documentation
Translation of Instructions for Use (IFUs) and User Manuals
Multilingual typesetting for packaging and labels

Disclaimer: The names used in this content have been changed to maintain security and confidentiality. Any resemblance to actual persons, living or dead, is purely coincidental.

To deliver technically precise and fully compliant translations of medical device documentation to ensure a successful, on-schedule product launch for Innovate Med-Tech in the European Union.

1. Strict Regulatory Compliance: All translated materials needed to meet the rigorous standards of the EU’s Medical Device Regulation (MDR) must be legally accepted.

2. High Technical Complexity: The documents contained highly specialised medical and engineering terminology related to surgical devices, where any inaccuracy could pose a safety risk.

3. Maintaining Consistency: A large volume of documentation (manuals, packaging, IFUs) needed to be translated, requiring absolute consistency in terminology across all materials.

4. Market-Specific Nuances: The translations had to be perfectly adapted for both the German and Swedish healthcare markets, requiring native-level expertise beyond simple translation.

1. Specialised Team Assembly: We assigned a dedicated team of NAATI-certified translators who were not only language experts but also subject matter experts with proven experience in medical device technology and EU MDR requirements.

2. Rigorous Quality Assurance: Our multi-stage review process ensured all technical terms were translated with complete accuracy. Every document was reviewed by a second senior translator for technical and linguistic precision.

3. Glossary Development: We worked with Innovate Med-Tech to create a client-specific glossary of approved technical terms. This glossary was enforced across the entire project to guarantee consistency.

4. In-Country Linguist Review: Native German and Swedish medical and healthcare translation experts performed a final review to ensure all content was culturally appropriate and perfectly clear for the end-users—medical professionals.

1. Full Regulatory Approval: The meticulously translated documentation was submitted to EU authorities and approved without any issues or requests for revision, meeting all MDR standards.

2. Successful Market Launch: With compliant documentation ready, Innovate Med-Tech launched its new product line on schedule in both Germany and Sweden, avoiding costly delays.

3. Positive Professional Reception: European partners and medical professionals praised the clarity and quality of the instructional materials, facilitating smooth product adoption and building immediate brand trust.

4. Significant Business Impact: The successful launch directly supported the company’s growth, contributing to a 20% increase in its European sales forecast for the upcoming fiscal year.

The successful completion of this project demonstrates the critical need for specialised, industry-specific translation services in regulated fields. By combining linguistic expertise with deep regulatory knowledge and a robust quality assurance process, we enabled Innovate Med-Tech to confidently and successfully expand into a new international market.

1. Expertise is Non-Negotiable: For high-risk industries like medical devices, translators must be proven subject matter experts to mitigate safety and compliance risks.

2. Proactive Glossary Creation: Establishing a glossary at the project’s start is essential for ensuring accuracy and consistency, especially in large-volume projects.

3. Regulatory Knowledge as a Service: A translation partner who understands the target market’s regulatory landscape provides immense value beyond mere translation.

4. Quality Prevents Compounding Costs: Investing in high-quality, compliant translation upfront prevents far greater costs down the line, including fines, recalls, and launch delays.