Translating Medical Device Documentation

Yellow Hub was the first language provider in Italy to achieve ISO 13485:2016+A11:2021 certification in managing multilingual documentation for producers and distributors in the life science and medical device sector. The selection and training of collaborators, continuous improvement, and process management with a risk-based approach are the regulatory aspects that most impact the treatment of multilingual content for pharmaceutical industries and healthcare organizations.

Focusing on Patients

Good multilingual information on the use of medical devices or the integration of healthcare regulations should adopt a precise, modern style that applies the principles of clarity and readability required by the standards. It should align with the various social backgrounds of patent holders, CMOs and CDMOs, regulatory bodies, scientists, and, above all, patients. It is our task to ensure that the content can be understood by very young or elderly patients, using clear, reassuring language that builds empathy and trust in the use of instruments for diagnosis and treatment. We should not forget that young people using the medical devices are also the same ones who use mobile phones and YouTube on a daily basis.

DispositiviMediciIndossabili

Wearable medical devices (wearables)

Surgical instruments

MonitoraggioDelPaziente

Monitoring devices

SistemiDiagnostica

Imaging diagnostic systems

ApparecchiatureDentali

Dental equipment

StrumentiOftalmici

Ophthalmology instruments

ApparecchiatureCardiovascolari

Cardiovascular/endovascular devices

SistemiOrtopedici

Orthopaedic systems

ImpiantiRespiratori

Respiratory equipment

Language Solutions for Medical Device Manufacturers

There are more than 500,000 different types of medical devices in the world. Whether they are wheelchairs, glasses, pacemakers, electrocardiographs, or catheters, we can assist you with our comprehensive translation solutions. Before launching your products on foreign markets, it is essential to check the wide range of regulations concerning product marking, labelling, and packaging in the European Union.

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