Medical Devices

Medical Devices

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.

CONTACT FORM

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BQT INC. USA
704 N. king Street Suite 500
Wilmington DE 19801. USA

BQT INC. Germany
Rosenheimer Straße 116
81669 Munich, Germany
+49 179 50 43 455

BQT INC. Europe
Shared Services Center Europe
Parque Empresarial ALVIA
C/ José Echegaray 8, Building 3, 1º Floor
28232 Las Rozas de Madrid, Spain
+34 91 086 1647

Sales: sales@bqtglobal.com
Shared Services Center: ssc@bqtglobal.com
Helpdesk: helpdesk@bqtglobal.com