Medical Device & diagnostic manufacturers operate in a highly regulated environment.
Each country has specific regulatory requirements and selling in the international market means complying with each one of them.
The most common requirement is for content to be available to users in their native language. Measures & units may also require localization as well as specific indications, labeling or contact information for regulatory bodies.
With our Best Practice Clearinghouse and ISO Quality Management System, BQT is well adapted to meet the highest standards of quality and rigor.
Our Quality Control steps ensure optimum quality from the start and efficient change management at the time of updating terminology and inserting validation feedback.
Our Medical Translation Team is familiar with most requirements, industry-specific terminology and directives such as the Medical Device Directive (MDD –Directive 93/42/EEC), Active Implantable Medical Devices (AIMDD – Directive 90/385/EEC), In Vitro Diagnostic Directive (IVDD – Directive 98/79/EC) or documents such as the Guidance MEDDEVs. Outside of Europe, BQT also follows regulations set by the Global Harmonization Task Force and the Chinese State Food and Drug Administration. In case of innovative products, or specific requirements, BQT will work with the Client to build a specific Translation Guide and will then train the entire team to ensure full awareness.