Risk Grading & Remediation Roadmaps for Investors. Independent assessments for investors, acquirers, and boards. Codebase quality, regulatory compliance gap analysis, scalability, and risk grading.

Technology Roadmaps Aligned with Regulatory Milestones. Define technology strategies grounded in clinical reality and commercial ambition.

Senior Guidance for Early-Stage Companies. Experienced leadership without a full-time hire. Team structuring, process design, technical hiring support, investor communications, and architecture selection.

Embedding compliance into development from day one as an advisory counterpart to RUN quality services. Expertise includes software requirements engineering, Design History File preparation, traceability verification, and Notified Body liaison — all of which help ensure audit readiness.

Documented, GDPR-Aligned AI Frameworks. A market-facing extension of our own AI-native operating model. Data classification, tool-access mapping, and approved-tools list design.

Advising on Evidence for CE Marking and FDA 510(k). Strategic advice distinct from operational implementation. Security architecture reviews and board briefings without full penetration testing.