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Alejandra Keller

Alejandra Keller is a German and Spanish native speaker with a high level of proficiency in English. She holds a translation degree from the University of Heidelberg and has lived and studied in Germany, the United States, Ireland, Spain and Peru. With a strong passion for international communication, she is currently working as Project Manager at AbroadLink.

Latest articles

MDR Language Requirements in Spain

Translation

Secure Spanish market access under the EU MDR by meeting language requirements for labeling, IFUs, and technical documentation with certified medical …

Alejandra Keller
26 Apr 2023 5 min read

MDR Language Requirements in Germany

Translation

Navigate Germany’s MDR language mandates with precision. This guide outlines mandatory translation requirements for labels, IFUs, declarations, and sa…

Alejandra Keller
19 Apr 2023 5 min read

MDR Language Requirements in France

Translation

Secure French market access under the MDR: identify mandatory French translations for labeling, IFUs, and conformity declarations, and implement certi…

Alejandra Keller
12 Apr 2023 4 min read

IDO: shoulder arthroplasty translated in multiple languages

Translation

Discover how clinical review, regulatory terminology, and distributor validation ensure MDR-compliant IFUs for Class III medical devices entering glob…

Alejandra Keller
7 Feb 2023 3 min read

MDR Language Requirements

Project Management

Navigate complex EU MDR language requirements across 30 member states, align patient and professional documentation with national laws, and implement …

Alejandra Keller
5 Jan 2023 5 min read

Medical Devices Existing Nomenclatures: EMDN, GMDN, UMDNS, CND

Business Abroad

Navigate the fragmented medical device nomenclature landscape and leverage EMDN harmonization to streamline regulatory submissions, ensure accurate cl…

Alejandra Keller
22 Dec 2022 4 min read

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