Role: Founder & Builder
Problem
Medical-device quality management still runs on paper binders, spreadsheets, and legacy systems that make audits painful and submissions slow. Compliance with FDA 21 CFR Part 820 and ISO 13485 is non-negotiable, but the tooling to achieve it is dated, expensive, and disconnected from how modern teams work.
Solution
SequenceQMS is a modern, cloud-based electronic Quality Management System (eQMS) built specifically for medical-device companies. It is FDA 21 CFR Part 820 compliant and ISO 13485 ready, with AI-powered quality management that helps teams manage quality, accelerate regulatory submissions, and stay continuously audit-ready.
Why It Matters
SequenceQMS sits at the intersection of deep medical-device regulatory expertise, an operational understanding of what quality teams actually need, and the engineering to ship a secure, AI-powered cloud product. Regulated-industry software, built by someone who has lived the regulations.
TODO(nick): add traction metrics (customers, devices managed, submission time saved) and confirm role/title framing.