Founder
Sequence Group, LLC
Sequence Group is a medical-device design, development, regulatory, and quality firm based in Fort Lauderdale, FL. It is the home of the FDA-cleared device portfolio below and of SequenceQMS, a modern cloud eQMS built for medical-device companies.
Portfolio
Medical devices & products
Medical Device
GentleBeam
FDA-cleared (K250692) image-guided visualization for superficial radiation therapy. Led design and development as PM, authored the entire 510(k), and submitted it to the FDA.
Medical Device
Robotic X-ray Beam-Steering Device
Architected a robotically controlled X-ray beam-steering system for precision superficial radiotherapy.
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.
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.