Hands-On Medical Device Executive
Bringing medical devices
to market.
Twenty-plus years in medical devices, from design and regulatory through FDA clearance and commercialization. Founder of Sequence Group, Limit Outfitter, and Protostar AI.
Founder
Three companies, built end to end
This site covers the medical-device and regulated work. Each company has its own home:
Founder
Sequence Group, LLC
Medical-device design, development, regulatory, and quality firm in Fort Lauderdale, FL. Home of the FDA-cleared device work and SequenceQMS.
sequencemedtech.comFounder
Protostar AI, LLC
AI software company. Its flagship product is a privacy layer for using public frontier models like Claude and ChatGPT on sensitive, regulated data.
protostarai.comFounder
Limit Outfitter, LLC
Outdoor brand for the modern outdoorsman: permit-lottery automation, weather tools, and a gear store.
limitoutfitter.comSequence Group · Services
Regulatory & quality services
End-to-end regulatory and quality support for medical-device companies, from quality systems and submissions to audits and US Agent representation.
Quality Management Systems
ISO 13485 QMS build, implementation, and remediation, from startup to scale.
ISO 13485
Gap assessments, implementation, and certification readiness.
FDA 510(k)
Submission strategy, authoring, and clearance, start to finish.
European MDR
CE marking and technical documentation under EU MDR 2017/745.
MDSAP
Medical Device Single Audit Program readiness across markets.
Auditing
Internal audits, supplier audits, and mock FDA / notified-body audits.
Product Development
Design controls and Design History Files from concept through launch.
US Agent Services
FDA US Agent representation for non-US manufacturers.
Sequence Group · 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.
Sequence Group · Flagship Product
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.
Let's build something.
Fractional leadership, product development, regulatory strategy, or AI.