Certified Medical Device Translation Services

No. Certification requirements vary according to the intended use of the translation, jurisdiction, regulatory pathway, authority, notified body, customer requirements, and the manufacturer’s own quality procedures. Some situations may require accurate translated documentation without prescribing a specific certification model, while a manufacturer’s internal SOP may require additional evidence such as a Certificate of Accuracy or translator qualifications.

There is no single blanket certification rule that applies to every medical device translation or every FDA context. Requirements should be evaluated according to the specific submission, document, and applicable FDA instructions. Sesen can work with the certification and documentation requirements established for the specific project.

The exact format depends on the project requirements. A Certificate of Accuracy may identify the translated material, applicable languages, project or document information, and an accuracy or completeness statement, together with the appropriate authorized signature or certification details. Where revisions are important, document or version identifiers can also help establish which translated deliverable the certificate supports.

A certified translation generally refers to a translated deliverable accompanied by a certification or accuracy statement appropriate to its intended use. ISO certification, by contrast, concerns a provider’s applicable management systems, translation processes, or quality framework. Sesen maintains ISO 17100, ISO 9001:2015, and ISO 13485:2016 certifications. These certifications support the processes surrounding multilingual work; they should not be interpreted as ISO individually certifying a particular translated document.

Qualification information can be incorporated when it forms part of the agreed project documentation requirements. The appropriate level of documentation should be defined during project intake so that resource selection and supporting records can be managed accordingly.

Yes. Certification documentation can be incorporated into IFU, labeling, and other medical-device translation projects when required or requested. The translation itself should still follow the appropriate document-specific workflow for terminology, professional review, formatting, usability, version control, and quality verification.

Not universally. Back translation may be useful or required for particular validation strategies, customer SOPs, documents, or project requirements, but it should not automatically be assumed to be necessary for every certified translation. Where back translation or reconciliation is required, Sesen can incorporate it into the agreed workflow.

Existing translations require appropriate evaluation before an accuracy certification can be considered. The necessary review or validation process depends on the source file, translation, document history, language, intended use, and certification requirements. Sesen can first assess the materials and determine an appropriate verification workflow rather than issuing certification without adequate review.

A source revision can affect the validity or applicability of the existing translated file and associated certification documentation. Sesen can identify the changed content, update the translation through an appropriate review workflow, verify the revised deliverable, and update the applicable certification documentation according to the project requirements.