mymunah-07lmtc/sahel-sound-triage-regulatory-strategy

A comprehensive regulatory plan for bringing an AI-powered lung and heart sound screener to market in Mali, ECOWAS, and WHO prequalification # Regulatory Strategy — Sahel Sound Triage Platform (SaMD) > A comprehensive regulatory plan for bringing an AI-powered lung and heart sound screener to market in Mali, ECOWAS, and WHO prequalification. --- ## 📌 Overview This document outlines the regulatory pathway for the **Sahel Sound Triage Platform v1.0** — a Software as a Medical Device (SaMD) that classifies lung and heart sounds to assist community health workers in rural Mali. --- ## 📄 Document Highlights | Section | Summary | |---------|---------| | **Device Classification** | EU MDR Class IIa (requires Notified Body) | | **Target Markets** | Mali → ECOWAS → WHO prequalification | | **Clinical Evidence** | Staged approach: pilot study (30–50 patients) → full validation (200–300 patients) | | **Quality Management** | ISO 13485, IEC 62304, ISO 14971 | | **Timeline** | 2–3 years (2026–2029) | | **Budget** | $40,000–$80,000 (phased) | | **AI Governance** | Subgroup performance review, drift monitoring, change control | --- ## 📊 Regulatory Pathway Pilot Study (Mali) → Clinical Validation → ISO 13485 → Mali Registration → ECOWAS Registration → WHO Prequalification --- ## 🎯 Why This Matters This document demonstrates: - **Market readiness** — understanding of regulatory requirements - **Strategic planning** — realistic timelines and budgets - **Clinical thinking** — evidence generation strategy - **Risk awareness** — identification of regulatory and operational risks - **Local context** — tailored to Mali and West Africa --- ## 📁 Repository Structure ``` sahel-sound-triage-regulatory-strategy/ ├── Sahel_Sound_Triage_Regulatory_Strategy.pdf # Full document ├── README.md # This file └── LICENSE # MIT License ``` --- ## 👩🏾‍💻 Author **Maimouna Tougoutcho Coulibaly** - GitHub: @mymunah-07lmtc - Email: maimounatc@gmail.com --- **Built with ❤️ by Maimouna Tougoutcho Coulibaly**