Professional Medical Translations to and from Swedish – Accurate, Confidential, and Compliant
For Contract Research Organizations and manufacturers of technical medical equipment, precision is not optional—it’s critical. Whether you're conducting clinical trials, preparing technical documentation, or submitting regulatory dossiers, our certified medical translation services to and from Swedish ensure that your content is scientifically accurate, terminologically consistent, and fully compliant with international standards.
We specialize in high-stakes medical content where accuracy, security, and speed are non-negotiable.
ISO-Certified Quality and Regulatory Assurance
Our services are certified under ISO 17100 for translation quality and ISO 27001 for information security. These standards guarantee that your documents are:
- Translated by subject-matter experts in clinical research and medical technology
- Reviewed through a multi-step quality assurance process (translation + revision)
- Protected by enterprise-level data security infrastructure
- Aligned with EU MDR, IVDR, FDA, and local regulatory requirements
We understand that your documents are not only technical—they are legally binding and life-impacting. That’s why we ensure linguistic precision and full regulatory traceability.
Our Expertise Covers:
For CROs:
- Clinical trial protocols, ICFs, CRFs, and patient-facing materials
- Investigator brochures, pharmacovigilance reports, and adverse event forms
- Study startup and site management documentation
- EMA, FDA, and Läkemedelsverket submission materials
For Medical Device Manufacturers:
- Technical documentation (TD), IFUs, and user manuals
- Product labels, packaging, and installation guides
- Clinical evaluation reports (CERs), risk analyses, and PMS reports
- Quality system documentation (ISO 13485, QMS files)
- Software UI strings, app interfaces, and companion diagnostics
All translations are handled by native-language medical linguists with backgrounds in biomedicine, engineering, or regulatory affairs.
Security and Confidentiality for Sensitive Documentation
CROs and medical device companies routinely manage proprietary, confidential data. As an ISO 27001-certified provider, we ensure end-to-end protection of your content through:
- Encrypted file transfer and secure storage
- Restricted document access with role-based permissions
- Legally binding NDAs for all linguists and staff
- GDPR and HIPAA compliance
Your data and intellectual property are safe with us—at every stage of the translation process.
Why Leading CROs and MedTech Firms Trust Us
- Certified under ISO 17100 & ISO 27001
- Subject-matter expertise in clinical and technical content
- Seamless handling of multilingual submissions for global markets
- Fast turnaround with scalability for large-volume projects
- Consistent terminology using custom termbases and translation memory
- Integration-ready files for eCTD, XML, DITA, and other structured formats
We support your clinical and regulatory workflows with scalable, high-precision translations—whether you’re launching a device, running a multi-country study, or preparing for audits.
How It Works:
1️⃣ Upload your documentation via our secure platform or API
2️⃣ Receive a tailored quote with timeline and compliance notes
3️⃣ We assign expert medical linguists with domain knowledge
4️⃣ Delivery in your required format (PDF, XML, InDesign, etc.), on time and audit-ready
Request a Quote Today
We partner with CROs and medical technology companies across Europe and globally. If you require accurate, fast, and secure Swedish translations for your clinical or technical documentation, get in touch today.
