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Development Forecast by JD-003

Purpose​

This document is a forecast of the development projects planned by JD-003 for the next years. It is intended to be used for planning grants and funding applications.

Keep in mind that the projects led by JD-005, JD-007, and JD-004 may be overlapping with this planning, since the JD-003 supervises these departments. Be sure to investigate their specific plans and timelines.

Projects​

Grants and Funding Planning

Overall Summary (Filtered)

Total Projects
7
Total Tasks
54
Total Cost
€2,305,000
Total Hours
1470d
By Purpose:
Access a new foreign market:9 tasks
Regulatory requirement for commercialisation:28 tasks
Development of a new product feature for commercial growth:18 tasks
By Country:
πŸ‡ΊπŸ‡Έ US:21 tasks
πŸ‡ͺπŸ‡Έ ES:8 tasks
🌐 All:25 tasks
β–Ά

ENS (Esquema Nacional de Seguridad) Certification

[HIGH]

Achieve ENS certification to comply with Spanish national security requirements for public healthcare contracts

πŸ“… 2025⏱️ 12 monthsπŸ’° €285,000πŸ“Š 8 tasks
β–Ά

ISO 27001 Information Security Management System

[HIGH]

Implement and certify ISO 27001 ISMS for global information security compliance

πŸ“… 2025⏱️ 14 monthsπŸ’° €310,000πŸ“Š 8 tasks
β–Ά

SOC 2 Type II Certification

[MEDIUM]

Achieve SOC 2 Type II certification for US market trust and compliance

πŸ“… 2026⏱️ 18 monthsπŸ’° €265,000πŸ“Š 7 tasks
β–Ά

FDA-Cleared Malignancy Detection Device

[HIGH]

Develop and certify new medical device focused on skin malignancy detection for US market

πŸ“… 2025⏱️ 24 monthsπŸ’° €875,000πŸ“Š 6 tasks
β–Ά

FDA 510(k) Clearance Process

[HIGH]

Obtain FDA clearance for malignancy detection device

πŸ“… 2026⏱️ 12 monthsπŸ’° €520,000πŸ“Š 8 tasks
β–Ά

Large Language Model Integration

[MEDIUM]

Integrate LLM capabilities for natural language interpretation of diagnostic results

πŸ“… 2025⏱️ 9 monthsπŸ’° €285,000πŸ“Š 8 tasks
β–Ά

Advanced Features and Reporting

[MEDIUM]

Expand product capabilities with new endpoints for referrals, urgency scoring, entropy analysis

πŸ“… 2025⏱️ 8 monthsπŸ’° €215,000πŸ“Š 9 tasks
Notes:
  • All cost estimations are in EUR
  • Hours are calculated based on 8-hour work days
  • Last updated: 2025-01-18
  • Created by: JD-003

Export Options​

This data can be exported from the JSON file at grants-data.json for use in grant applications, financial planning, and resource allocation. The component above provides filtering and summary capabilities to help identify projects matching specific grant criteria.

Strategic Alignment​

The projects listed above align with Legit.Health's strategic goals of:

  1. Market Expansion: Entering the US market through FDA certification
  2. Security Compliance: Achieving ENS, ISO 27001, and SOC 2 certifications
  3. Product Innovation: Integrating LLM capabilities and expanding features
  4. Regulatory Compliance: Meeting requirements for different markets

Funding Sources to Consider​

  • EU Horizon Europe: For AI and medical device innovation
  • Spanish CDTI: For R&D and international expansion
  • NIH SBIR/STTR: For US market clinical validation
  • EIC Accelerator: For scaling and market deployment
  • Regional grants: Basque Government innovation programs
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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.)