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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
    • Planning
    • Red.es RedIA Salud 2025
    • EPIC-X 2026
      • Instructions (CLAUDE.md)
      • Application
        • Section 1: Executive Summary
        • Section 2: Excellence and Innovation (40 Points)
        • Section 3: Impact and Market Potential (25 Points)
        • Section 4: Implementation and Capacity (35 Points)
        • Section 5: Business Coaching Plan (10 Points)
        • Section 6: Women Leadership (10 Points)
      • Resources
      • EPIC-X Grant Application - Data Request for Teams
      • EPIC-X 2026 Grant Application: Gap Analysis & Prioritization
      • EPIC-X 2026 Application - Quality Review Checklist
  • Pricing
  • Public tenders
  • Grants
  • EPIC-X 2026
  • Application
  • Section 4: Implementation and Capacity (35 Points)

Section 4: Implementation and Capacity (35 Points)

This section addresses the Implementation and Capacity evaluation criteria (35 points total):

  • C.1 Quality and Feasibility of Work Plan (20 points) - Milestones, timeline, deliverables, risk management
  • C.2 Team and Resources (10 points) - Expertise, track record, organizational capacity
  • C.3 Budget and Cost-Effectiveness (5 points) - Appropriate allocation, ROI, co-financing

C.1 Quality and Feasibility of Work Plan (20 Points)​

Project Objectives (Aligned with EPIC-X Program Duration)​

Timeline: 6 months (April 1 - September 30, 2026)

Primary Objectives:

  1. US Market Entry via FDA 510(k) Clearance

    • Target: FDA clearance obtained by Q4 2026
    • Interim milestone: Pre-submission meeting completed Q2 2026, submission filed Q3 2026
  2. Series A Fundraising (EUR 5-10M)

    • Target: Term sheet signed by Q3 2026, funding closed Q4 2026
    • Interim milestone: 20+ investor meetings conducted, 2+ term sheets received
  3. European Hospital Partnerships (Germany, France, Italy)

    • Target: 3-5 pilot contracts signed by Q3 2026
    • Interim milestone: 15+ C-suite decision-maker meetings, pilot proposals submitted
  4. Women Leadership Visibility Platform

    • Target: 5+ conference talks delivered, 3+ media features published by Q3 2026
    • Interim milestone: Conference speaking engagements secured, PR strategy launched

12-Month Work Plan (Q2 2026 - Q1 2027)​

Quarter 1 (April - June 2026)​

Month 1 (April 2026):

WeekObjectiveKey ActivitiesDeliverablesOwnerCoaching Module
1-2FDA Pre-Submission Prep- Kick-off meeting with FDA regulatory coach
- Predicate device analysis
- Clinical data package review
- FDA pre-submission meeting deck (draft v1.0)Andy + Regulatory TeamModule 1 (Day 1-2)
2-3Series A Investor Targeting- Kick-off with fundraising coach
- VC target list creation (20+ funds)
- Pitch deck review session
- Investor target list
- Pitch deck v2.0 (draft)
Andy + CFOModule 2 (Day 1-2)
3-4European Market Research- Germany/France/Italy hospital landscape analysis
- Procurement process research
- Pilot proposal template creation
- Market entry strategy doc (Germany/France/Italy)Commercial TeamModule 3 (Day 1)
4PR Strategy Launch- Kick-off with PR coach
- Conference target list creation
- LinkedIn content calendar
- 12-month PR calendar
- Conference applications submitted
Andy + MarketingModule 4 (Day 1)

Month 2 (May 2026):

WeekObjectiveKey ActivitiesDeliverablesOwnerCoaching Module
5-6FDA Pre-Submission Meeting- Final pre-submission deck preparation
- Mock FDA Q&A session with coach
- FDA pre-submission meeting
- FDA meeting minutes
- FDA feedback incorporation plan
Andy + RegulatoryModule 1 (Day 3-4)
6-7Investor Outreach (Round 1)- First 10 investor meetings
- Pitch refinement based on feedback
- Financial model finalization
- Investor meeting logs
- Pitch deck v2.1
- 3-year financial model
Andy + CFOModule 2 (Day 3-4)
7-8European C-Suite Meetings- Germany: Charité Berlin, University Hospital Heidelberg meetings
- Pilot proposal presentations
- 5+ C-suite meetings held
- Pilot proposals submitted (Germany)
Commercial TeamModule 3 (Day 2-3)
8Conference Speaking (First Talk)- First conference talk delivered (e.g., EIT Health Summit)
- LinkedIn post-talk content
- Conference talk delivered
- LinkedIn engagement metrics
AndyModule 4 (Day 2)

Month 3 (June 2026):

WeekObjectiveKey ActivitiesDeliverablesOwnerCoaching Module
9-10FDA 510(k) Submission Prep- Clinical data package finalization
- Labeling and indications review
- QSR compliance audit
- 510(k) submission package (95% complete)Regulatory TeamModule 1 (Day 5)
10-11Investor Outreach (Round 2)- Second 10 investor meetings
- Term sheet negotiation coaching
- Due diligence preparation
- 20+ investor meetings total
- 1-2 term sheets received
Andy + CFOModule 2 (Day 5-6)
11-12European Pilot Negotiations- France: AP-HP network meetings
- Italy: Lombardy regional health system meetings
- Contract negotiation
- Pilot contract negotiations ongoing (France/Italy)Commercial TeamModule 3 (Day 4)
12Media Features (First Article)- First media feature published (e.g., TechCrunch Europe)
- Press kit finalization
- Media article published
- Press kit
Andy + PR AgencyModule 4 (Day 3)

Q1 Summary Deliverables:

  • ✅ FDA pre-submission meeting completed, feedback incorporated
  • ✅ 20+ investor meetings conducted, 1-2 term sheets received
  • ✅ 10-15 C-suite meetings (Germany/France/Italy)
  • ✅ 1-2 conference talks delivered, 1 media feature published

Quarter 2 (July - September 2026)​

Month 4 (July 2026):

WeekObjectiveKey ActivitiesDeliverablesOwner
13-14FDA 510(k) Submission- Final submission package review
- FDA submission portal upload
- Submission confirmation
- FDA 510(k) submitted
- FDA acknowledgment letter
Regulatory Team
14-15Series A Term Sheet Negotiation- Term sheet review with coach
- Valuation negotiation
- Due diligence coordination
- Term sheet signed (target)
- Due diligence checklist
Andy + CFO
15-16European Pilot Contract Signatures- Germany pilot contract finalization
- France pilot contract finalization
- 1-2 pilot contracts signedCommercial Team
16Conference Speaking (Second Talk)- Second conference talk (e.g., HIMSS Europe)
- Networking with hospital decision-makers
- Conference talk deliveredAndy

Month 5 (August 2026):

WeekObjectiveKey ActivitiesDeliverablesOwner
17-18Series A Due Diligence- Investor due diligence support
- Legal documentation review
- Cap table preparation
- Due diligence materials provided
- Legal docs in progress
CFO + Legal
18-19European Pilot Implementation- Germany pilot kick-off
- France pilot kick-off
- Training for hospital staff
- Pilot implementations started (2 sites)Clinical Team
19-20Mentorship Program Launch- Women in deep-tech mentorship program design
- Mentee recruitment (10 mentees)
- Mentorship program launchedAndy

Month 6 (September 2026):

WeekObjectiveKey ActivitiesDeliverablesOwner
21-22Series A Funding Close- Final legal negotiations
- Wire transfer coordination
- Cap table update
- Series A closed (EUR 5-10M)
- Funding announcement
Andy + CFO
22-23European Contract Expansion- Italy pilot contract finalization
- Additional Germany/France pilots
- 3-5 total pilot contracts signedCommercial Team
23-24Thought Leadership (Final Push)- Conference talks 3-5 delivered
- Media features 2-3 published
- LinkedIn content series
- 5+ total conference talks
- 3+ total media features
Andy
24EPIC-X Program Wrap-Up- Final reporting to EPIC-X
- Outcomes documentation
- Alumni network engagement
- EPIC-X final report submittedAndy

Q2 Summary Deliverables:

  • ✅ FDA 510(k) submitted (acknowledgment received)
  • ✅ Series A funding closed (EUR 5-10M)
  • ✅ 3-5 European pilot contracts signed
  • ✅ 5+ conference talks delivered, 3+ media features published
  • ✅ Mentorship program launched (10 mentees)

Quarter 3-4 (October 2026 - March 2027): Post-EPIC-X Execution​

Month 7-9 (October - December 2026):

  • FDA 510(k) review process (FDA response expected Q4 2026)
  • Series A capital deployment: Team scaling (10 new hires), US market entry preparation
  • European pilot execution and data collection

Month 10-12 (January - March 2027):

  • FDA 510(k) clearance (target: Q4 2026 or Q1 2027)
  • US hospital pilots (1-2 contracts signed)
  • European pilot conversion to full contracts (3-5 sites)

Deliverables Summary (Aligned with EPIC-X 6 Tasks)​

EPIC-X TaskDeliverableOwnerDeadlineStatus Tracking
1. Legal Entity Form (Annex 2)Corporate documentation, financialsFinanceDec 19, 2025External (Google Docs)
2. Women's Leadership Declaration (Annex 3)Ownership/board evidenceAndy/HRDec 19, 2025External (Google Docs)
3. Business Coaching Plan (Annex 4)4-module coaching planAndyDec 19, 2025Section 5 of this application
4. Market Fit & Investment DocsHospital contracts, CDTI grant, revenue dataCommercial/FinanceDec 19, 2025Section 3 + supporting docs
5. Online Application FormComplete application (6 sections)AndyJan 5, 2026This document (Sections 1-6)
6. 2-Minute Pitch VideoVideo pitch (Andy presenting)Andy/MarketingJan 5, 2026YouTube/Vimeo link

Risk Management​

Risk Register (Top 5 Risks):

Risk IDRisk DescriptionLikelihoodImpactMitigation StrategyContingency PlanOwner
R1FDA 510(k) delays (review >6 months)MediumHigh- Early pre-submission meeting (Q2 2026)
- Comprehensive clinical data package
- EPIC-X coaching (Module 1)
- Alternative: EU-first expansion while awaiting FDA
- Accelerate European revenue to offset US delay
Regulatory
R2Series A fundraising shortfall (<EUR 5M)Low-MediumHigh- 20+ investor pipeline (diversification)
- Strong traction (EUR 192K won, 7 studies)
- EPIC-X coaching (Module 2)
- Bridge financing from existing CDTI grant
- Extend runway via cost controls
- Consider EUR 3-5M raise if market conditions weak
CFO
R3European pilot delays (procurement bureaucracy)MediumMedium- Early C-suite engagement (Q2 2026)
- Procurement process coaching (Module 3)
- Flexible pilot contract templates
- Focus on fast-moving hospitals
- Pivot to private clinics if public system too slow
- Leverage existing Spain relationships for warm intros
Commercial
R4Key personnel loss (CEO, Head MDS, Regulatory)LowHigh- Competitive compensation (Series A proceeds)
- Stock option retention incentives
- Strong company culture and mission alignment
- Succession planning for critical roles
- External recruitment via VC network
- Interim consultants for specialized roles
Andy/HR
R5Competitive entry (large med device incumbents)MediumMedium- Regulatory moat (CE MDR Class IIb, FDA 510(k))
- Clinical validation (7 studies, 6 publications)
- Hospital relationships (switching costs)
- Accelerate product development (expand to 400+ conditions)
- Deepen hospital integrations (lock-in via workflows)
- Strategic partnerships with pharma
Andy/Product

Risk Monitoring:

  • Monthly risk review meetings (Andy + leadership team)
  • Quarterly risk report to board
  • Escalation protocol for high-impact risks materializing

C.2 Team and Resources (10 Points)​

Leadership Team: Proven Track Record​

CEO & Co-Founder: Sheyla Andina Aguilar (Andy Aguilar)​

Background (Full biography in Section 6):

  • Education: B.B.A. from Tecnológico de Monterrey (2011-2016), Marketing (UPV/EHU), Exchange (University of Mississippi)
  • Recognition: Forbes 30 Under 30, Forbes 100 Most Creative Individuals in Business
  • Entrepreneurial Experience: 4 ventures before Legit.Health (Gïk Live!, LegeBot, Hola Plates, News-Worth Creation)
  • Legit.Health Tenure: CEO since founding (September 2017, 8+ years)

Key Achievements:

  • Secured CE MDR Class IIb certification (2023) - highest regulatory bar for medical AI
  • Won EUR 2.5M CDTI Sello de Excelencia grant (2024)
  • Established 7 clinical validation studies with 1000+ patients
  • Scaled team from 3 founders to 31 FTEs
  • Generated EUR 192K+ in won contracts

Responsibilities:

  • Strategic direction and company vision
  • Fundraising and investor relations (Series A target: EUR 5-10M)
  • Partnership development (hospitals, pharmaceutical companies)
  • Women leadership visibility and thought leadership

Management Team​

RoleNameBackgroundKey Achievements
CTO (Chief Technology Officer)[UPDATE: Name][UPDATE: Education, experience]- Technical architecture design
- Engineering team leadership (X FTEs)
Head of Medical Data Science[UPDATE: Name]PhD in [AI/ML/Computer Vision], [X] years experience- AI model development (239 conditions)
- Clinical validation studies
Head of Regulatory Affairs[UPDATE: Name]Regulatory affairs experience in medical devices- CE MDR certification leadership
- FDA 510(k) strategy
Head of Commercial[UPDATE: Name]Healthcare sales/BD background- EUR 695K+ contracts closed (2020-2025)
- Hospital partnership pipeline
CFO (Chief Financial Officer)[UPDATE: Name]Finance background, startup experience- CDTI grant management
- Series A fundraising preparation

Board of Advisors (if applicable):

NameRole/ExpertiseAffiliationContribution to Legit.Health
[UPDATE: Name]Dermatology clinical expert[Hospital/University]Clinical validation guidance, hospital introductions
[UPDATE: Name]Regulatory affairs (FDA/EMA)[Consulting firm]Regulatory strategy for US/EU markets
[UPDATE: Name]Healthcare VC investor[VC fund]Fundraising coaching, investor introductions

Organizational Capacity​

Team Composition (31 FTEs, December 2024)​

DepartmentFTEsKey RolesWomen %
Medical Data Science[UPDATE: Count]ML Engineers, Data Scientists, Computer Vision Researchers[UPDATE: %]
Software Engineering[UPDATE: Count]Full-stack developers, DevOps, QA[UPDATE: %]
Regulatory & Quality[UPDATE: Count]Regulatory Affairs Managers, QA Specialists[UPDATE: %]
Clinical[UPDATE: Count]Clinical Research Coordinators, Medical Advisors[UPDATE: %]
Commercial[UPDATE: Count]Sales, Business Development, Customer Success[UPDATE: %]
Finance & Operations[UPDATE: Count]Finance, HR, Legal, IT[UPDATE: %]
TOTAL31[UPDATE: Overall %]

Post-Series A Hiring Plan (Q4 2026 - Q1 2027):

RoleCountRationaleTimeline
Medical Data Scientists+2US market models (FDA-specific validation), rare disease focusQ4 2026
Commercial (US)+2US hospital sales, reimbursement strategyQ1 2027
Commercial (EU)+2Germany/France/Italy market developmentQ4 2026
Regulatory Affairs (US)+1FDA post-market surveillance, US complianceQ1 2027
Software Engineers+2US EHR integrations (Epic, Cerner), scalabilityQ4 2026
Clinical Study Coordinators+1US clinical studies coordinationQ1 2027
TOTAL NEW HIRES+10Q4 2026 - Q1 2027

Organizational Certifications​

CertificationIssuing BodyCertificate #Issue DateValiditySignificance
ISO 13485:2016 (QMS)BSI (British Standards Institution)[UPDATE: Certificate #][Year][Renewal date]Quality Management System for medical devices - prerequisite for CE/FDA
CE MDR Class IIbBSI (Notified Body 2797)[UPDATE: Certificate #]2023[Renewal: 2028]EU Medical Device Regulation conformity - highest AI/ML device class
GDPR ComplianceInternal audit + legal reviewN/A (ongoing)2018 (GDPR effective)OngoingEU data protection compliance for patient data

Track Record: Demonstrated Execution Capability​

8+ Years of Continuous Operation (September 2017 - present):

  • Founded during early wave of medical AI development (pre-GPT era)
  • Survived COVID-19 pandemic disruption (2020-2021)
  • Pivoted from B2C to B2B2C model based on market feedback (demonstrating adaptability)

Regulatory Clearances (4 markets):

  1. CE MDR Class IIb (EU) - 2023
  2. AEMPS (Spain) - 2021 (ES-MD2021-0027)
  3. MHRA (UK) - [Year]
  4. ANVISA (Brazil) - [Year]
  5. FDA 510(k) (US) - In progress (2025-2026)

Clinical Validation (7 studies, 1000+ patients):

  • Consistent execution of prospective clinical studies across multiple hospitals
  • Published 6+ peer-reviewed papers in dermatology and AI journals
  • Established credibility with pharmaceutical companies (Boehringer Ingelheim n=1000 study)

Fundraising Success:

  • CDTI Sello de Excelencia grant (EUR 2.5M) - competitive government validation
  • Managed non-dilutive financing to date (maintaining founder control)

Commercial Traction:

  • EUR 695K+ in won contracts (Janssen EUR 220K+, Sagimet EUR 156K, Boehringer EUR 127K, historical contracts EUR 192K+)
  • Diverse customer base (hospitals, pharmaceutical companies, teledermatology platforms)
  • Proven ability to close enterprise sales cycles (6-12 months), including multi-year pharma partnerships

C.3 Budget and Cost-Effectiveness (5 Points)​

EUR 60,000 Grant Allocation​

Budget Breakdown:

CategorySubcategoryAmount% of GrantJustificationExpected ROI
US Market EntryFDA regulatory consultantsEUR 10,00016.7%Expert guidance on 510(k) submission, pre-submission meeting prepFDA clearance = 330M population access
US clinical validationEUR 5,0008.3%Bridging studies for FDA requirementsClinical data package completion
US market researchEUR 3,0005.0%Hospital landscape analysis, reimbursement pathwaysTargeted US sales strategy
Legal (US entity setup)EUR 2,0003.3%Delaware C-corp or LLC for US operationsUS market operational readiness
FDA 510(k) SubmissionFiling feesEUR 10,00016.7%FDA user fees (~USD $12,000)FDA review process initiated
Predicate device analysisEUR 3,0005.0%Substantial equivalence documentation510(k) submission quality
Labeling complianceEUR 2,0003.3%US labeling requirements (21 CFR Part 801)FDA approval likelihood ↑
European PartnershipsGermany market entryEUR 5,0008.3%Market research, pilot proposals, travel to hospital meetings2+ pilot contracts (Germany)
France market entryEUR 5,0008.3%AP-HP procurement research, contract templates1-2 pilot contracts (France)
Italy market entryEUR 3,0005.0%Regional health system navigation1 pilot contract (Italy)
Legal (EU contracts)EUR 2,0003.3%Pilot contract review, procurement complianceContract risk mitigation
Women LeadershipConference participationEUR 4,0006.7%Travel, registration for 5+ conferences (EIT Health, HIMSS Europe)Visibility, C-suite networking
PR agency retainerEUR 3,0005.0%6-month PR retainer for media outreach (3+ features)Media visibility, thought leadership
LinkedIn/social mediaEUR 2,0003.3%Content creation, sponsored posts, professional photography+2,000 followers, brand building
Mentorship programEUR 1,0001.7%Platform setup, materials for 10 menteesWomen in deep-tech ecosystem impact
TOTALEUR 60,000100%EUR 250K+ ARR Year 1 (4.2x return)

Co-Financing (EUR 230,000+)​

Legit.Health Cash Contribution:

CategoryAmountSourcePurpose
Personnel (6 months)EUR 150,000Operating cashAndy (CEO), Regulatory team, MDS team, Commercial team salaries during EPIC-X program
InfrastructureEUR 30,000Operating cashCloud computing (AWS), GPU clusters, data storage for US/EU deployments
Clinical studies (ongoing)EUR 50,000CDTI grant + revenueContinued validation studies in Europe (data collection, dermatologist time)
TOTAL CASHEUR 230,000

In-Kind Contributions:

  • Andy Aguilar time commitment: 25% of CEO time dedicated to EPIC-X coaching and execution (~EUR 40K opportunity cost)
  • Office space and equipment (Bilbao headquarters)
  • Existing regulatory infrastructure (ISO 13485 QMS, CE MDR compliance processes)

Total Co-Financing: EUR 230,000 cash + EUR 40,000 in-kind = EUR 270,000

Leverage Ratio: EPIC-X EUR 60,000 / Total project EUR 330,000 = 18.2% grant funding, 81.8% co-financing


Return on Investment (ROI)​

Direct ROI (12-Month Revenue Impact):

Investment CategoryGrant AmountRevenue Impact (12 Months)ROI Multiple
US Market Entry + FDAEUR 35,000EUR 100,000 ARR (2 US hospital pilots)2.9x
European PartnershipsEUR 15,000EUR 150,000 ARR (3-5 EU pilots)10x
Women LeadershipEUR 10,000EUR 0 (indirect: visibility → partnerships)Indirect
TOTALEUR 60,000EUR 250,000 ARR4.2x

Indirect ROI (Enabled by EPIC-X Coaching):

OutcomeValueCoaching Module AttributionROI Calculation
Series A FundingEUR 5-10MModule 2 (Fundraising, EUR 7,000)714-1,429x coaching investment
FDA ClearanceEUR 500K+ ARR (2027-2028)Module 1 (FDA, EUR 5,000)100x+ over 2 years
EU Market AccessEUR 300K+ ARR (2027)Module 3 (Partnerships, EUR 5,000)60x over 2 years
Thought Leadership10 mentees launched, 500+ inspired at conferencesModule 4 (Visibility, EUR 3,000)Ecosystem impact (non-monetizable)

Total ROI Summary:

  • Year 1 Direct Revenue: EUR 250K (4.2x grant)
  • Series A Capital Mobilized: EUR 5-10M (83-167x grant)
  • 2-Year Cumulative Revenue: EUR 800K+ (13x grant)
  • Strategic Value: FDA clearance (330M population access) = incalculable

Cost-Effectiveness Comparison​

Alternative Scenarios (without EPIC-X grant):

ScenarioCostTimelineOutcomeCost-Effectiveness vs. EPIC-X
Hire FDA consultant independentlyEUR 50,000+6 monthsSame FDA clearance, but slower and more expensive1.4x more expensive, 6-month delay
Fundraising advisor retainerEUR 30,000+3 monthsSeries A raised, but weaker terms (no EPIC-X coaching)4.3x more expensive for Module 2
European BD team expansionEUR 120,000 (2 FTEs)+12 monthsSame 3-5 pilots, but hiring + onboarding delay8x more expensive for Module 3
PR agency annual retainerEUR 36,00012 monthsSimilar visibility, but no EPIC-X network access12x more expensive for Module 4
TOTAL ALTERNATIVE COSTEUR 236,000+6-12 months delay3.9x more expensive than EPIC-X

EPIC-X Value Proposition:

  • Coaching efficiency: EUR 20,000 for 20 days of expert coaching (EUR 1,000/day) vs. market rate EUR 2,000-3,000/day for comparable consultants
  • Network access: EPIC-X alumni, EIT connections, European Commission visibility = priceless
  • Timeline acceleration: 6-month focused program vs. 12-18 month bootstrapped approach

Conclusion: Implementation Readiness & Capacity​

Legit.Health demonstrates exceptional implementation readiness and organizational capacity:

✅ Feasible Work Plan (C.1): Detailed 12-month roadmap with quarterly milestones, monthly deliverables, and weekly activities. Risk register addresses top 5 risks with mitigation and contingency plans. Aligned with EPIC-X 6-task deliverables.

✅ Proven Team (C.2): 8+ years track record, 4 regulatory clearances, 7 clinical studies, EUR 192K+ contracts. Leadership team with deep expertise (CEO, CTO, Regulatory, MDS, Commercial). ISO 13485 certified organization.

✅ Cost-Effective Budget (C.3): EUR 60,000 grant allocated across 4 strategic priorities (US 58.3%, EU 25%, Women 16.7%). EUR 270,000 co-financing (4.5x grant). 4.2x direct ROI in Year 1, 83-167x ROI via Series A, 3.9x more cost-effective than alternative approaches.

This combination of detailed planning, organizational excellence, and cost-effectiveness ensures EPIC-X's EUR 60,000 investment will generate maximum impact for both Legit.Health's growth and the broader deep-tech ecosystem.

Previous
Section 3: Impact and Market Potential (25 Points)
Next
Section 5: Business Coaching Plan (10 Points)
  • C.1 Quality and Feasibility of Work Plan (20 Points)
    • Project Objectives (Aligned with EPIC-X Program Duration)
    • 12-Month Work Plan (Q2 2026 - Q1 2027)
      • Quarter 1 (April - June 2026)
      • Quarter 2 (July - September 2026)
      • Quarter 3-4 (October 2026 - March 2027): Post-EPIC-X Execution
    • Deliverables Summary (Aligned with EPIC-X 6 Tasks)
    • Risk Management
  • C.2 Team and Resources (10 Points)
    • Leadership Team: Proven Track Record
      • CEO & Co-Founder: Sheyla Andina Aguilar (Andy Aguilar)
      • Management Team
    • Organizational Capacity
      • Team Composition (31 FTEs, December 2024)
    • Organizational Certifications
    • Track Record: Demonstrated Execution Capability
  • C.3 Budget and Cost-Effectiveness (5 Points)
    • EUR 60,000 Grant Allocation
    • Co-Financing (EUR 230,000+)
    • Return on Investment (ROI)
    • Cost-Effectiveness Comparison
  • Conclusion: Implementation Readiness & Capacity
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.)