Medical Device Translations
Medical Device Translations
Read about our medical device translation department. As a medical sepcialized translation agency, we are well aware of the regulations and requirments of this field.
Compliance Intelligence
Regulatory Mapping
94%
Jurisdiction requirements mapped before launch.
Terminology Integrity
99.1%
Clinical terms locked with controlled glossary logic.
Protocol Automation
4.1x
Faster execution with AI-assisted workflow routing.
Audit Assurance
ISO
Traceable process chain designed for compliance review.
Protocol Architecture
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.
Our Vagus Software gives you the ability to manage the project yourself with our team of translators being at your disposal and under your full supervision, like an in-house team. You will have the ability to choose your team out of our pool of medical translators, clinicians, regulatory consultants, and reviewers, we will build the working program with you using our customized software that will be able to ensure all procedures are compatible with regulations (like MDR 2017/745, ISO13845:2016) and that all deadlines are met.
Execution Snapshot
Since localization responsibility is assigned to manufacturers in many regions, choosing the right medical linguistics partner becomes a regulatory decision, not just a language decision.