Medical Technology – Expert Translations for the Highest Standards
In the field of medical technology, precision is everything – and that includes language. User manuals, technical documentation, risk reports, or IFUs (Instructions for Use) must not only be translated with accuracy, but also adapted in full compliance with international regulations. After all, when it comes to regulatory approval and the safe use of medical devices, linguistic precision is a critical factor.
Bohemian Dragomans® is your certified translation partner for medical technology content – accurate, standards-compliant, and backed by deep subject-matter expertise.
Our Medical Technology Translation Services
We provide expert translations for manufacturers and suppliers in the medtech sector, including:
- Content for websites and trade fairs
- Instructions for Use (IFUs), Directions for Use (DFUs), and user manuals
- Marketing materials and product catalogs
- Product dossiers and CE marking documentation
- Packaging and labeling content
- Risk management reports and declarations of conformity
- Technical documentation in line with MDR/IVDR
- Test reports, performance data, and technical specifications
- Training materials, service manuals, and installation guides
Where Language Meets Engineering
Our translators bring specialized training or professional backgrounds in medical technology, biotechnology, or related engineering fields. They are familiar with regulatory requirements – from MDR and ISO 13485 to FDA standards – and ensure that your content is not only linguistically correct, but also technically sound and tailored to your target audience.
Supported by state-of-the-art CAT tools, translation memories, and well-maintained terminology databases, we ensure consistent terminology and cost efficiency – even for large-scale or long-term projects.
Certified Quality According to DIN EN ISO 17100
As a language service provider certified to DIN EN ISO 17100, we offer structured workflows, standardized quality assurance, and fully documented processes. Every translation undergoes at least the four-eyes principle; upon request, we also apply a six-eyes process including an additional subject-matter review.
We also work in full compliance with GDPR and adhere to DIN EN ISO 9001 principles – especially relevant for safety-critical or regulatory-sensitive content.
Your Benefits with Bohemian Dragomans®
- Translators with a technical and medtech background
- Consistent terminology through curated glossaries and translation memories
- Standards-compliant processes in line with DIN EN ISO 17100
- Full consideration of regulatory requirements (MDR, IVDR, FDA, etc.)
- Secure and GDPR-compliant data handling
- Personal support from technically experienced project managers