Medical Device Translations

Medical devices are clinical products used by patients, humans, or used on them in a medical procedure, diagnosis, therapy, etc. Worldwide, the regulation of these products is getting more strict as they have medical and health implications. To be able to meet the needs of regulators, manufacturers need to provide seamless and prompt document localization and translation process. We provide a customized medical device translation protocol that is constantly updated for every locality and jurisdiction. This protocol is written by our medical expert teams and clinical experts, respecting local regulations, international best practices, and ISO certifications.

Since Medical device localization responsibility is being assigned to the manufacturer by the regulatory entities in many countries, manufacturers have to be careful choosing the best translation and cultural localization experts to avoid any regulatory delays. Our Approach towards medical device translation is based on combining local regulations, ISO 13845:2016 standards, and best quality assessment standards ( J2450 Translation Quality Metric). Furthermore, we provide cultural and local clinical consultation to localize the content to multiple localities, languages, and cultures. This enables us to provide a customized approach taking into account, translation, layout, setting, and more.

Do you want to learn more about our plan and protocols for your specific product?

Class I devices are low-risk devices.

Class II devices are intermediate-risk devices.

3-Class III devices are high-risk devices.

We provide our services to all category devices, however, the approach differs.

Mobile Applications.

Elderly Aids and appliances.

High-frequency ventilators.