Danish Medical Translation Services for CROs and Medical Device Manufacturers
Clinical trials, medical devices, and pharmaceutical documentation require more than just translation—they require expertise, precision, and complete confidentiality. We offer professional medical translations to and from Danish, tailored to the needs of Contract Research Organizations and manufacturers of technical medical equipment.
Our services are ISO-certified and designed for high-stakes medical content where accuracy is mission-critical.
ISO-certified quality and compliance
Our agency is certified to ISO 17100 for translation quality and ISO 27001 for information security. This ensures:
- Every translation is handled by qualified linguists with medical or technical specializations
- Terminology is consistent and aligned with EMA, FDA, MDR, and IVDR requirements
- Translations undergo a full quality control workflow (translation, revision, review)
- Data confidentiality and secure handling are guaranteed throughout
We support clients operating in tightly regulated environments with precision and reliability.
Expertise across clinical and technical documentation
We provide medical and technical translations across the entire product lifecycle, from development to post-market surveillance.
For CROs:
- Clinical trial protocols, ICFs, CRFs, and patient materials
- Investigator brochures, adverse event reports, and monitoring logs
- Regulatory submissions for Danish authorities and EMA
- Study agreements, SOPs, and internal documentation
For medical device manufacturers:
- Instructions for use (IFUs), technical files, and labeling
- CERs, risk analyses, PMS/PMCF reports
- Quality system documentation (ISO 13485) and compliance materials
- Software UI, e-health applications, and digital interfaces
Our translators are native speakers with domain expertise in medicine, biotech, and engineering.
Data security and document confidentiality
As an ISO 27001-certified translation provider, we protect all client data through:
- End-to-end encryption and secure file exchange
- Confidentiality agreements with all team members
- Access restriction protocols
- Compliance with GDPR, HIPAA, and Swiss data protection laws
You can trust us to handle your most sensitive documentation securely.
Why CROs and MedTech companies choose us
- ISO 17100 and ISO 27001 certified for quality and security
- Specialized medical translators with clinical and technical expertise
- Full compliance with Danish and international regulatory requirements
- Fast, scalable workflows for projects of any size
- Delivery in your preferred format: XML, eCTD, InDesign, PDF, etc.
- Support for over 60 language pairs
We understand your industry’s language—both medically and operationally.
How it works
1️⃣ Upload your files securely via our encrypted platform
2️⃣ Receive a custom quote with pricing and delivery details
3️⃣ We assign the project to a qualified Danish medical translator
4️⃣ You receive a fully reviewed, regulatory-compliant translation, on time
Request a quote today
Whether you’re submitting clinical documentation, preparing a device for the Danish market, or translating technical files for international audits—we’re here to help.
Get in touch now or upload your documents for a free, no-obligation quote. Accurate, secure, and delivered on time.
Let’s ensure your medical communication speaks clearly—across borders.
