ServiceUpdated on 27 January 2025

Gap Analysis

Tabatha Bourgois

Director, Regulatory and Clinical Development at Alira Health

Barcelona, Spain

About

> Customized report identifying the critical differences between the current state of the device development and where the company would like to be (i.e. product certification, Clinical Investigation Initiation, IVDR or MDR compliance, 21 CFR)

> Recommendations on how to solve the gaps identified and next steps to be carried out

> Recommendations on how to transit from one regulation/region to another

Organisation

Alira Health

CRO/SMO

Boston, United States

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