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  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
      • R-009-001 Implementation plans
        • R-009-001 Iderma 20230301
        • R-009-001 Sermas 20230301
        • R-009-001 Galderma 20230727
        • R-009-001 Boehringer Ingelheim 20240207
        • R-009-001 Hospital del Mar 20240709
        • R-009-001 ES Boehringer Ingelheim 20241223
        • R-009-001 ES Generalitat Valenciana licitacion contrato menor 20250107
        • R-009-001 ES Licitación SESPA 20250101
        • R-009-001 US Sagimet ICON 20250113
        • R-009-001 ES Sandoz 20250407
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-009 Sales
  • R-009-001 Implementation plans
  • R-009-001 ES Boehringer Ingelheim 20241223

R-009-001 ES Boehringer Ingelheim 20241223

  • Deal Id: 20652951404

Goals​

Primary Goal:​

The customer implements Legit.Health's medical device to achieve the following goal(s):

GoalMetricTarget
Improvement in diagnostic accuracy and diagnosis times for rare conditions (GPP)Patients1

Secondary Goals​

GoalMetricTarget
Successful implementation of the Legit.Health medical device in hospitalsHospitals10
Evaluate the impact of the device on improving the diagnosis of rare dermatological conditionsPatients__
Enhance and personalize physician training using data generated by the medical devicePractitioners__
Evaluate and ensure high satisfaction among healthcare professionals regarding the device using the Clinical Utility Questionnaire (CUS)Clinical Utility Questionnaire (CUS)__%

Project timeline and milestones​

To achieve the goals, the parties agree on the following timeline.

Hospital-level Goal​

GoalMetricTarget
Evaluar la implementación del dispositivo médico Legit.Health en el entorno hospitalario, específicamente en el diagnóstico y manejo de patologías dermatológicas.Implementación exitosa del dispositivo en hospitales dermatológicosImplementar en 10 hospitales
Evaluar el impacto del dispositivo en la mejora diagnóstica de patologías dermatológicas rarasMejora en la precisión diagnóstica y tiempos de diagnóstico en patologías raras (GPP)Aumento del __% en precisión diagnóstica
Enriquecer y personalizar la capacitación de los médicos utilizando datos generados por el dispositivo médicoNúmero de médicos capacitados y datos obtenidos del dispositivoCapacitar a __ médicos en 10 hospitales
Evaluar y garantizar una alta satisfacción entre los profesionales sanitarios respecto al dispositivo mediante el Cuestionario de Utilidad Clínica (CUS)Encuesta de satisfacción de los usuarios del dispositivo en su práctica clínicaLograr una satisfacción del __% o superior

General implementation timeline Hospital-level​

To achieve the goals, the parties agree on the following timeline.

La Coruña Hospital timeline​

To achieve the goals, the parties agree on the following timeline.

Reason for project loss: The dermatologist who was going to lead the project at the hospital has taken on the position of head of the department and will not have time to participate in the project.

Figuerres Hospital timeline​

To achieve the goals, the parties agree on the following timeline.

Project tasks​

TaskDescriptionResponsible
Conception and initiationProject conception and initiationDeal Owner, JD-013, JD-008
Definition and planningDefine project detailsDeal Owner, JD-013, JD-008
Follow-up MeetingsWeekly Follow-up Meetings: Regular meetings held each week to track progress, address challenges, and ensure alignment on project goals. These meetings provide an opportunity to discuss updates, resolve issues, and coordinate next steps among team members.JD-007, JD-010, JD-013
Hospital RecruitmentRecruiting and selecting hospitals for participationDeal Owner, JD-013, JD-008
Set up of the platformSet up the platform for the projectJD-007, JD-010, JD-013
OnboardingProvide training to the participants before conducting the questionnaire.JD-014
Customer supportProvide support to the participants to address any questions or concerns.JD-014
Data analysisStatistical analysis of results.JD-014
Follow up reportPrepare and present a follow-up report based on collected data.JD-005, JD-009
Follow up meetingConduct follow-up meeting to discuss progress and findings.Deal Owner, JD-016
Final reportAnalyze the final results and prepare the final report.Deal Owner, JD-005, JD-009
Next stepsIdentify and define the next steps for post-project activities and future initiatives.Deal Owner, JD-016, JD-021, (JD-013)

Acceptance Specifications​

The project will be deemed accepted when:

  • The web application is fully functional and integrates with the HCPs’ existing systems.

  • 60,000 diagnostic reports are accessible with AI-driven insights.

  • The system meets security, compliance, and performance standards.

  • HCPs successfully onboard and validate usage.

Project task tracker​

TaskDescriptionStart DateEnd DateStatusNotes
Contract signedOfficial signing of the project contract2025-04-14TBD⏳ PendingContract finalized and signed by both parties
Delivery of platformDelivery of access credentials to team2024-03-24TBD⏳ PendingAccess keys delivered to teams for implementation
Custom dashboard developmentDesigning and implementing a custom dashboard2025-04-07TBD⏳ Pending
Project launch (Production)Official launch of the project where it is fully operational and available for use in production.2025-07-15TBD⏳ Pending
Customer SupportProviding assistance and support to users2025-07-15TBD⏳ Pending
Project follow upConduct follow-up meeting to discuss progress and findings.2026-07-15TBD⏳ Pending

Project tasks: Hospital-level​

TaskDescriptionResponsible
Conception and initiationProject conception and initiationDeal Owner, JD-013, JD-008
Definition and planningDefine project detailsDeal Owner, JD-013, JD-008
Set up of the platformSet up the platform for the projectJD-007, JD-010, JD-013
OnboardingProvide training to the participants before conducting the questionnaire.JD-014
Customer supportProvide support to the participants to address any questions or concerns.JD-014
Data analysisStatistical analysis of results.JD-014
Follow up reportPrepare and present a follow-up report based on collected data.JD-005, JD-009
Follow up meetingConduct follow-up meeting to discuss progress and findings.Deal Owner, JD-016
Final reportAnalyze the final results and prepare the final report.Deal Owner, JD-005, JD-009
Next stepsIdentify and define the next steps for post-project activities and future initiatives.Deal Owner, JD-016, JD-021, (JD-013)

Project leads​

TeamCodeLeader of
Legit.HealthJD-002, JD-008, JD-019Sales Manager, Business Development Manager, Sales Development Representative, Digital Health Manager
Legit.HealthJD-003, JD-013Design and Development Manager, Project Manager
Legit.HealthJD-018Clinical Research Manager
Legit.HealthJD-004Quality Manager & PRRC
Legit.HealthJD-007, JD-010Technology Manager, Software developer
Legit.HealthJD-005, JD-009Machine Learning Manager, Medical Data Scientist
Legit.HealthJD-014Data Analyst
Legit.HealthJD-016Customer Success Manager
Legit.HealthJD-021Account Manager
Company NameName SurnameProject Director
Company NameName SurnameProject lead

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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  • Goals
    • Primary Goal:
    • Secondary Goals
  • Project timeline and milestones
    • Hospital-level Goal
  • General implementation timeline Hospital-level
  • La Coruña Hospital timeline
  • Figuerres Hospital timeline
  • Project tasks
  • Acceptance Specifications
  • Project task tracker
  • Project tasks: Hospital-level
  • Project leads
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)