Regulatory certainty. Global market launch. Terminology that matters.
Regulatory certainty. Global market launch. Terminology that matters.
Language services for medicine, pharmaceuticals and life sciences
The global distribution of medical devices, pharmaceutical products, and life science solutions requires accurate, regulatory-compliant translations into every target market. For over 50 years, leading manufacturers have relied on KERN Global Language Service’s specialist translations to communicate their products worldwide in a safe, understandable, and legally compliant manner. Our expertise is geared toward the most important industries and target groups that rely on highly specialized translations.
Reliable translations for SmPCs, package inserts, prescribing information, and regulatory documents for the EMA and FDA—compliant with standards and approved by authorities.
Precise translations for IFUs, technical documentation, declarations of conformity, and risk files—fully MDR and CE compliant.
Translations for study protocols, ICFs, and CRFs, including linguistic validation and back translation for maximum regulatory compliance.
Professional translations for publications, patents, IVD documents, and research proposals at the international peer review level.
Are you interested in translation or interpreting services in the field of medical technology, pharmacy, or life sciences?
Translation requirements for medical technology, pharmaceuticals, and life sciences
Life sciences, medical technology, and pharmaceuticals combine the highest level of technical complexity with strict regulatory requirements. Mechanical engineering combines maximum technical complexity with strict safety requirements and international quality standards. Our focus is on the following areas:
- Medical FieldsHuman medicine, laboratory medicine, dentistry, veterinary medicine
- Life Sciences & ResearchBiotechnology, diagnostics, clinical trials, regulatory documentation
- Industry & TechnologyMedical technology, pharmaceuticals, agricultural technology
- International StandardsFDA/EMA compliant, MDR compliant, HIPAA certified
What we translate for you
From regulatory documents and product information to clinical documentation: we translate all key content throughout the entire product life cycle—accurately, in compliance with standards, and tailored to the target audience.
Medical technology – precision and regulatory compliance
Medical technology requires clear and precise language, especially when documenting safety instructions, technical specifications, and declarations of conformity. Our specialist translators are familiar with the regulatory requirements of the industry and have experience in translating technical documentation.
Translations of user manuals, labeling, and technical documentation in particular are necessary for medical devices. These must not only be linguistically correct, but also adapted to the respective local regulations. This requires both medical and technical expertise.
What we translate:
- Instructions for Use (IFU)
- Technical documentation and specifications
- Declarations of conformity
- Risk management documentation
- Labeling and marking
- CE marking and MDR 2017/745-compliant documentation
Special features:
- Security for line breaks and layout requirements
- Cultural adaptation (e.g. different warning symbols for each target country)
- Compliance with national regulatory requirements
Pharmaceutical products – FDA and EMA compliance
In the pharmaceutical sector, translation tasks include clinical studies, research reports, packaging, and regulatory submissions. The translations must be extremely accurate, as they directly affect the safety and efficacy of medicines. KERN offers specialized translations for the pharmaceutical industry, where the highest level of accuracy is required. Our translators have in-depth knowledge of pharmaceutical fields and ensure that all documents comply with legal and regulatory requirements. What we translate:
- Summary of Product Characteristics (SmPC)
- Package inserts and patient information
- Instruction leaflets
- Approval dossier
- Specialist information for physicians
- Clinical studies and research reports
Special features:
- EMA and FDA compliant documentation
- Balance between technical language and patient comprehensibility
- Regulatory requirements for different markets
Biotechnology – Scientific Precision
For the biotechnology industry, KERN translates scientific papers, technical documents, patents, and more. This supports global cooperation and knowledge exchange in this innovative field.
Specialized translators ensure that the correct terminology is used and that scientific works are made accessible internationally.
What we translate:
- Scientific publications
- Patents and patent applications
- Technical documentation
- Research collaborations and exchanges of ideas
- In vitro diagnostics (IVD) documentation
- Research proposals and grant applications
Special features:
- Peer review standard for publications
- Precise scientific terminology
- International publication requirements
- Interpreting at international conferences
Agrotechnology – Sustainability and Innovation
In agrotechnology, documents relating to agricultural technologies are often translated with the aim of improving sustainability and productivity in agriculture. Here, too, precise terminology plays a central role.
Specialized technical translators ensure that the correct terminology is used and that innovative solutions are understood worldwide.
What we translate:
- Agricultural technology documentation
- Agricultural innovations
- Sustainability and productivity documents
- Technical manuals for agricultural equipment
- Research reports and studies
Special features:
- Specific agricultural terminology
- Local regulatory requirements
- Cultural adaptation for different agricultural markets
Additional language services for the life sciences
However, KERN’s activities are not limited to the processing of medical, pharmaceutical, and medical technology documents, but also include extensive support for foreign-language communication in the field of life sciences.
HIPAA-certified translations
At KERN Global Language Services, we understand the immense importance of protecting sensitive health information. Our commitment to privacy and security is highlighted by our HIPAA-certified translation services, which are specifically designed to meet the rigorous requirements of the Health Insurance Portability and Accountability Act (HIPAA).
What makes our HIPAA-certified services special?
At KERN Global Language Services, your data is in safe hands. Choose a partner who understands the importance of data protection and security in healthcare while providing excellent translation services. Trust in our HIPAA-certified translation services – your security is our priority.
- Specialist staff: As well as being proficient in their own language specialties, our translators are also specially trained and qualified to deal with HIPAA regulations. That ensures all translated documents comply with the highest standards for data protection and data security.
- Highest data protection priority: In the sensitive area of health information, we attach the utmost importance to the security and confidentiality of your data. Our HIPAA certificationdemonstrates our continued commitment to ensuring security at every stage of the translation process.
- Quality and compliance: The integration of HIPAA-compliant processes into our quality management system underlines our commitment to the highest quality standards. Our healthcare customers can be confident that their documents will be handled according to strict HIPAA guidelines.
Foreign-language services in the medical and pharmaceutical field
Sales of pharmaceutical products and medical equipment are generally not limited to the domestic market. Translations of the highest quality are needed for all countries in which the products will be sold. Numerous leading manufacturers of medical equipment and products as well as well-known pharmaceutical companies have been trusting KERN’s medical and pharmaceutical translations for over 50 years.
FAQs about the life sciences industry
You will find answers to the most important questions about medical technology, pharmaceuticals, and life sciences here shortly.
What does KERN's translation service cover in the field of medical technology and pharmaceuticals?
KERN offers expert translations and localizations for the medical and pharmaceutical sectors, e.g. for operating instructions for medical devices, package inserts, approval documents, studies, medical reports, and regulatory texts.
Which specialist areas of the medical technology and pharmaceutical industry does KERN cover?
The service covers human, dental, and veterinary medicine, laboratory medicine, medical technology and medical devices, pharmacy, nutrition & health, and all related fields such as research and clinical documentation.
How does KERN guarantee quality and standard-compliant translations in the sensitive medical and pharmaceutical sectors?
All projects are handled in accordance with recognized quality standards, including ISO 17100 and ISO 13485. Translations are reviewed by expert translators and specialists to ensure accuracy in terms of content and terminology.
Which documents and text types can be translated?
This includes package inserts and leaflets, instructions for use for medical devices, clinical findings, studies and scientific publications, approval and regulatory documents, and patient information.
Is terminology management part of the offering?
Yes. KERN offers the development and maintenance of terminology databases, glossaries, and translation memory systems to ensure consistent terminology across all documents and languages.
Who is KERN's medical technology and pharmaceutical service suitable for?
The service is aimed at medical device manufacturers, pharmaceutical companies, laboratories, research institutes, clinics, and other organizations that need to use or translate medical or pharmaceutical documents internationally.
Why should you choose professional translations over automated tools?
Because medical and pharmaceutical texts must meet high technical, regulatory, and linguistic requirements. Only specialist translators with medical expertise and appropriate quality control can guarantee accurate, reliable, and compliant translations.