Regulatory compliance. Precise terminology. Translation solutions tailored to your project.
Regulatory compliance. Precise terminology. Translation solutions tailored to your project.
A trusted partner for medical technology projects
Leading medical technology companies rely on KERN for precise, secure, and scalable translation solutions.
Language services for medicine, pharmaceuticals and life sciences
Whether you need an IFU translated for a medical device, ICFs for a clinical study, pharmaceutical documentation for submission, or scientific content for an international research project, KERN provides specialized translation services tailored to the requirements of each individual project.
Depending on your project’s requirements, we can provide a fully human translation workflow or integrate suitable translation technologies and AI-supported processes. The approach is scalable and customizable, allowing you to choose the right combination of specialist expertise, technology, quality assurance, turnaround time, and cost for each project.
Specialist pharmaceutical translations for SmPCs, package inserts, prescribing information, labeling, regulatory submissions, and other pharmaceutical documentation, with workflows tailored to the requirements of your target markets.
Precise IFU translations and translations of technical documentation, labeling, declarations of conformity, risk management documentation, and other content relating to medical devices and in-vitro diagnostics.
Professional ICF translations (Informed Consent Forms), study protocols, CRFs, patient-facing materials, clinical study documentation, and supporting content, including linguistic validation and back translation where required.
Specialized translations for biotechnology, diagnostics, scientific publications, patents, research proposals, laboratory documentation, and other scientific and technical content.
Do you have a translation project in the fields of pharmaceuticals, medical devices, biotechnology, or clinical and scientific research?
Translation requirements for medical technology, pharmaceuticals, and life sciences
Accuracy, specialist terminology, quality, and compliance are central to every life sciences translation project. Our translation services focus on the following core areas:
- Medical DevicesIFUs, technical documentation, labeling, declarations of conformity, risk management documentation, and documentation for medical devices and IVDs.
- BiotechnologyDocumentation for biotechnology and diagnostics, laboratory content, patents, product information, and specialist technical materials.
- Clinical & Scientific ResearchICFs, study protocols, CRFs, patient materials, publications, research documentation, and scientific communications.
- Regulatory RequirementsProject-specific workflows can take relevant requirements and standards into account, including requirements relating to the FDA, EMA, MDR, and HIPAA.
What we translate for you
From a single Instructions for Use (IFU) or Informed Consent Form (ICF) to extensive multilingual regulatory documentation, we provide translation services tailored to the scope, terminology, quality requirements, and deadlines of your individual project.
Our expertise covers translations for:
Medical devices: precise IFU and technical translations
Medical device translation requires particularly precise terminology and clear communication, especially for content concerning product use, patient and user safety, technical specifications, and regulatory documentation.
KERN provides specialist translations for medical device projects of different sizes and complexity. This includes IFU translations, labeling, technical documentation, declarations of conformity, and risk management documentation.
What we translate:
- Instructions for Use (IFUs)
- Technical documentation and specifications
- Declarations of conformity
- Risk management documentation
- Labeling and marking
- Documentation relating to CE marking and MDR 2017/745
- Software and user-interface content
- Patient and healthcare-professional materials
Special features:
- Terminology consistency across multilingual documentation
- Preservation of formatting and layout requirements
- Localization for individual target markets
- Workflows adapted to regulatory and project requirements
- Flexible quality assurance according to document type and intended use
Pharmaceuticals: precise translations for regulatory and patient-facing content
Pharmaceutical translation requires a high level of linguistic accuracy and consistent specialist terminology, particularly when content is intended for regulatory authorities, healthcare professionals, or patients.
KERN provides specialized translation services for pharmaceutical projects of different sizes and complexity, from product information and package leaflets to regulatory submissions and supporting documentation.
What we translate:
- Summaries of Product Characteristics (SmPCs)
- Patient Information Leaflets (PILs) and package inserts
- Prescribing information
- Regulatory submissions and documentation
- Product labeling and packaging content
- Patient and healthcare professional materials
- Pharmacovigilance and safety documentation
- Marketing authorization documentation
Special features:
- Consistent pharmaceutical and medical terminology
- Translation workflows adapted to regulatory requirements
- Quality assurance tailored to the document type and intended use
- Localization for individual target markets
- Support for complex multilingual translation projects
Biotechnology: specialist translations for complex scientific content
Biotechnology combines highly specialized scientific terminology with rapidly developing technologies and international research and commercialization. Clear and accurate translation is therefore essential when communicating complex information across languages and markets.
KERN supports biotechnology translation projects covering scientific, technical, regulatory, and commercial documentation. Our language specialists work with subject-specific terminology to ensure that complex concepts are communicated accurately and consistently.
What we translate:
- Scientific and technical documentation
- Laboratory and research documentation
- Biotechnology product documentation
- Diagnostics and IVD-related content
- Patents and patent-related documentation
- Scientific publications and manuscripts
- Research proposals and reports
- Product and marketing materials
Special features:
- Specialist terminology for complex scientific subjects
- Terminology management across documents and projects
- Translation by appropriately qualified language specialists
- Consistency across multilingual scientific documentation
- Flexible workflows for different content and quality requirements
Clinical & scientific research: translations for studies and international research
Clinical trials and international research projects generate a wide range of specialist documents for investigators, regulators, healthcare professionals, study participants, and patients. Accurate translation is particularly important for patient-facing documents such as Informed Consent Forms (ICFs), where complex information needs to be communicated clearly and appropriately.
KERN provides specialized clinical research translation services, from individual ICF translations to extensive multilingual study documentation. Our services can also include linguistic validation and back translation where these are required within the project.
What we translate:
- Informed Consent Forms (ICFs)
- Study protocols
- Case Report Forms (CRFs)
- Patient Information Sheets (PIS)
- Patient-reported outcome materials
- Investigator documentation
- Clinical study and trial documentation
- Scientific publications and research reports
Special features:
- Clear translation of patient-facing materials
- Consistent terminology across study documentation
- Linguistic validation where required
- Back translation where appropriate
- Scalable workflows for multilingual clinical research projects
Additional language services for the life sciences
KERN can combine translation with additional language services to create a customizable end-to-end solution for each project. Rather than applying the same workflow to every document, the process can be adapted to your content, languages, volumes, deadlines, regulatory requirements, and quality objectives.
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?
- 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.
FAQs about the life sciences industry
You will find short answers to the most important questions about medical technology, pharmaceuticals, and life sciences here.
What types of life sciences translation projects does KERN support?
KERN supports translation projects in the folllowing main areas: pharmaceuticals, medical devices, biotechnology, and clinical and scientific research. Projects can range from individual documents to large multilingual documentation packages.
Does KERN provide IFU translations for medical devices?
Yes. KERN translates Instructions for Use (IFUs) as well as labeling, technical documentation, declarations of conformity, risk management documentation, specifications, and other medical device content.
Does KERN provide ICF translations for clinical trials?
Yes. KERN provides Informed Consent Form (ICF) translations as well as translations of study protocols, CRFs, patient-facing materials, and other clinical trial documentation. Linguistic validation and back translation can also be incorporated where required.
Which pharmaceutical documents can KERN translate?
Pharmaceutical translation projects can include SmPCs, package leaflets, prescribing information, labeling, regulatory documentation, product information, patient materials, and other specialist pharmaceutical content.
How does KERN ensure translation quality and terminology consistency?
The translation and quality-assurance workflow can be configured according to the document type, target languages, purpose, regulatory requirements, terminology, and risk profile of the individual project. Terminology management can also be incorporated to maintain consistency across documents and languages.
Do you use AI for life sciences translations?
There is no one-size-fits-all workflow. Depending on the project’s content, purpose, regulatory requirements, confidentiality, volume, and quality expectations, KERN can provide anything from fully human specialist translation to technology- and AI-supported translation workflows with appropriate professional review.
Can KERN manage multilingual life sciences translation projects?
Yes. Translation, localization, terminology management, review, quality assurance, and additional language services can be combined into a customized workflow for multilingual projects.