Portfolio
Work
Regulated medical devices taken from concept through clearance, and software & AI products shipped end-to-end.
Medical Devices
Devices that reached the clinic
Regulated medical devices taken from concept through clearance and commercialization.
Security Program
HIPAA & Cybersecurity Program
Security, HIPAA, and risk program for connected medical devices and health data.
Medical Device
Treatment Planning System
Clinical treatment-planning software for radiotherapy workflows.
Medical Device
Sculptura
Medical-device program led from concept through development.
Medical Device
Balloon Applicator
Balloon applicator technology for targeted radiotherapy delivery.
Regulated Software
Software for regulated companies
Compliance-grade software built and shipped end to end on modern cloud infrastructure.
SequenceQMS
Modern cloud-based electronic Quality Management System for medical-device companies, FDA 21 CFR Part 820 compliant, ISO 13485 ready, with AI-powered quality management.