ServiceUpdated on 27 January 2025

Product Classification and Categorization

Tabatha Bourgois

Director, Regulatory and Clinical Development at Alira Health

Barcelona, Spain

About

> Determine main Mode of Action and product categorization (MD, IVD, Combination product, Drug, etc.)

> Classify the device according to the EU MDR and IVDR and/or the US FDA guidelines

> Review similar devices in the EU/US markets

> Provide recommendations on product claims and intended use

Type

  • Consulting

Organisation

Alira Health

CRO/SMO

Boston, United States

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