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Services

Medical and Regulatory Translation

Specialised Language Support for Regulated Life Sciences Content

NN Translations provides specialised translation for clinical, pharmaceutical, regulatory, medical device and patient-facing content across more than 200 languages. Our services are delivered within an ISO 9001 and ISO 17100 certified quality framework.

We support clinical trial sponsors, Contract Research Organisations (CROs), COA licensing companies, eCOA providers, pharmaceutical and biotechnology companies, and medical device and IVD manufacturers with language workflows adapted to the content, intended audience, regulatory context and project requirements.

Our focus extends beyond linguistic accuracy to terminology consistency, clarity, cultural appropriateness and controlled documentation, with workflows adapted to the regulatory context, intended audience and requirements of each project.

Specialist Areas

Content We Support

COA and eCOA Content

Translation support for:

Patient-Reported Outcome (PRO)

Clinician-Reported Outcome (ClinRO)

Observer-Reported Outcome (ObsRO)

Performance Outcome measures (PerfO)

When a COA is translated or adapted for use across languages and target populations, we manage it through our dedicated Linguistic Validation workflow to support conceptual equivalence, cultural appropriateness and the collection of comparable clinical outcome data.

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Clinical Research Content

Study documentation and materials used by clinical teams, sites and participants, including:

clinical trial protocols and protocol synopses;

informed consent forms and participant information;

investigator and site materials;

clinical study reports;

safety communications;

training and study support materials

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Medical Devices and IVDs

We provide specialised translation for IFUs, labelling, patient-facing materials, clinical and regulatory documentation, and other medical device and IVD content.

Projects requiring source-content preparation can also include IFU Content Optimisation and Regulatory Support, delivered where appropriate in collaboration with experienced regulatory affairs consultants.

Content we support includes:

Instructions for Use, product manuals and user guides;

labelling, packaging and patient-facing materials;

technical documentation and regulatory submissions;

Clinical Evaluation Reports, Performance Evaluation Reports and safety documentation;

medical device clinical trial and clinical investigation documentation;

Summary of Safety and Clinical Performance documents;

post-market surveillance and vigilance documentation;

quality management and manufacturing documentation;

product training and eLearning materials; and

scientific, technical and market-facing product content

Where required, medical device projects can also be coordinated with usability testing through experienced specialist partners, including evaluation of user-facing information in the intended-use context.

Medical Device Therapeutic and Clinical Areas

Cardiovascular and Vascular Care +

Documentation for cardiac monitoring, vascular interventions and implantable devices, including pacemakers, stents and catheters.

Orthopaedics, Spine and Rehabilitation +

Content for joint replacements, spinal systems, trauma fixation, prostheses and devices supporting mobility and rehabilitation.

Neurology and Neurostimulation +

Documentation for neurological monitoring, diagnostic equipment and stimulation devices used in brain, spinal and peripheral nerve care.

Surgery and Minimally Invasive Procedures +

Content for surgical instruments, robotic systems, endoscopic equipment and devices used in general and reconstructive surgery.

Oncology and Medical Imaging +

Documentation for diagnostic imaging, radiotherapy systems and devices used in cancer investigation and treatment.

Respiratory, Anaesthesia and Sleep Medicine +

Content for ventilators, airway management devices, anaesthesia systems, oxygen therapy and sleep monitoring equipment.

Ear, Nose and Throat Care +

Documentation for hearing devices, cochlear implants and diagnostic and surgical equipment used in ENT care.

Dermatology, Aesthetics and Wound Management +

Content for dermatological lasers, aesthetic treatment devices, wound dressings and advanced wound therapy systems.

Dental and Oral Health +

Documentation for dental implants, orthodontic systems, imaging equipment, instruments and restorative materials.

Diabetes, Endocrinology and Digestive Health +

Content for glucose monitoring, insulin delivery and devices used in gastrointestinal diagnosis and treatment.

Ophthalmology and Vision Care +

Documentation for ophthalmic diagnostic equipment, intraocular lenses, contact lenses and eye surgery systems.

Urology and Renal Care +

Content for urinary catheters, dialysis equipment and devices used in urological and kidney care.

Women’s and Reproductive Health +

Documentation for gynaecological devices, intrauterine devices, fertility technologies and maternal monitoring equipment.

Pharmaceutical and Regulatory Content

Specialised translation for pharmaceutical, biotechnology and regulatory workflows, including:

product information and labelling;

Summaries of Product Characteristics;

Patient Information Leaflets;

regulatory correspondence and submission content;

safety and pharmacovigilance documentation;

quality and manufacturing documentation;

medical and scientific communications

For Patient Information Leaflets, we can also coordinate Readability Testing of PILs and, where appropriate, bridging evaluation and related testing strategies through experienced specialist partners.

Discuss Your Life Sciences Translation Project

Contact us with your content type, source and target languages, intended audience, expected word count, reference materials and required timeline.