BeaconPoint AI Systems
Clinical AI • Regulated ML • Digital Health Strategy
Clinical AI • Regulated ML • Digital Health Strategy
BeaconPoint AI Systems is a boutique consulting practice specializing in clinical AI, regulated machine learning, and digital health strategy. We help MedTech, pharma, and digital health teams build AI systems that are safe, effective, and aligned with global regulatory expectations. Our work spans evidence generation, SaMD strategy, ML change management, and end‑to‑end support for AI‑enabled product development.
Founded by Ranga Narayanaswami, an engineer and clinical AI specialist with deep experience in regulated ML, medical device analytics, and digital health innovation.
We help teams define regulatory‑aligned pathways for AI/ML‑enabled products, including SaMD classification, evidence expectations, PCCP design, and global submission strategy.
Support across study design, dataset strategy, performance evaluation, bias assessment, and real‑world evidence generation for AI/ML systems in clinical workflows.
End‑to‑end guidance across design controls, ML lifecycle management, risk analysis, documentation, and readiness for regulatory review and post‑market change management.
BeaconPoint brings a rare combination of clinical AI depth, regulatory clarity, and hands‑on ML development experience. We operate at the intersection of engineering, evidence generation, and global regulatory expectations, helping teams move faster while staying aligned with FDA, EU, and emerging AI/ML frameworks. Our approach is pragmatic, technically grounded, and designed for teams building real products—not theoretical slideware.
We support teams across the healthcare and life sciences ecosystem, including:
MedTech and medical device companies
Digital health and SaMD startups
Pharma and clinical development groups
AI/ML engineering teams building regulated products
Clinical operations and evidence‑generation teams
Innovation, R&D, and strategy organizations
Work With Us
If you’re building AI/ML‑enabled products in healthcare or life sciences, we’d be happy to help. Reach out to discuss your project or explore how BeaconPoint can support your team.