Tabatha Bourgois

Director, Regulatory and Clinical Development

Alira Health

Barcelona, Spain

19 profile visitsSpeaker

My organisation

Alira Health

Alira Health

CRO/SMO

Boston, United States

About me

Social media

Additional questions

I am a/an

Speaker

Speaker sessions (1)

Wednesday, 26 February 2025

13:30 - 14:00

MDR - IVDR transition consultant experiences

Location:AmazonasTrack:Round Table Discussion
  • PLENARY SESSION 2: MDR/IVDR transition experiences

Marketplace (9)

  • Service

    Regulatory Strategy

    Customized report evaluating the regulatory requirements (e.g. MDR/IVDR/FDA) and tests needed according to the applicable standards.

    • Medtech
    • Consulting
    • Biotech and Lifescience
    Author

    Tabatha Bourgois

    Director, Regulatory and Clinical Development at Alira Health

    Barcelona, Spain

  • Service

    Gap Analysis

    Critical differences between the current state of device's development and where you would like to be.

    Author

    Tabatha Bourgois

    Director, Regulatory and Clinical Development at Alira Health

    Barcelona, Spain

  • Service

    Due Diligence Assessment

    Report identifying and assessing important regulatory issues of an asset.

    • Consulting
    Author

    Tabatha Bourgois

    Director, Regulatory and Clinical Development at Alira Health

    Barcelona, Spain

  • Service

    Clinical Strategy

    Clinical Development Plan, Study design, Synopsis and Protocol preparation.

    • Consulting
    Author

    Tabatha Bourgois

    Director, Regulatory and Clinical Development at Alira Health

    Barcelona, Spain

  • Service

    Go-to-market Strategy

    GTM Strategies encompassing Regulatory, Clinical and Commercial requirements.

    • Consulting
    Author

    Tabatha Bourgois

    Director, Regulatory and Clinical Development at Alira Health

    Barcelona, Spain

  • Service

    FSP Model

    Functional Service Provision: outsourced Regulatory team as part of client’s cross-functional team.

    • Consulting
    • Development
    Author

    Tabatha Bourgois

    Director, Regulatory and Clinical Development at Alira Health

    Barcelona, Spain