Governed to Global Standards. Built for Long-Term Medical Device Scale.

369 Innovations operates with enterprise-grade governance, IP clarity, and transparent commercial models—ensuring regulatory confidence, IP protection, and predictable value creation for OEMs, partners, and investors.

In regulated medical device environments, execution is only as strong as the governance behind it. Our operating model is designed to meet the expectations of global OEMs, notified bodies, and institutional investors—combining structured oversight, clearly defined IP ownership, and scalable revenue frameworks. This allows our partners to innovate faster, manufacture confidently, and scale globally without governance risk.

Structure

Oversight structure

IP Strategy & Ownership Model

Revenue & Engagement Models

Traction Signals

Capital Deployment

Oversight Structure

Board of Directors – Strategy, capital allocation, global alliances

Clinical & Regulatory Advisory Board – Ex-FDA / EU MDR consultants, clinicians

Technology & IP Council – Architecture, FTO, platform roadmap

Manufacturing & Quality Committee – ISO 13485, supplier audits, design transfer

Compliance & Quality (Measured)

ISO 13485–aligned QMS → 100% of programs governed

IEC 62304 (Software Lifecycle) → Class B/C architectures

ISO 14971 Risk Files → Maintained for every SKU

IEC 60601 / 80601 → Pre-compliance electrical & EMC testing

FDA Design Controls (21 CFR 820) → DHF for all regulated products

EU MDR → Clinical evaluation + technical documentation workflows

Operational Metrics

TRL gates enforced: TRL 2 → TRL 8

Requirement traceability: >95% RTM coverage

Critical audit findings: Zero across pilots