Co-founder and CEO of Sequenex, an ISO 13485-certified software product development firm. We build regulated software for medical device companies: Software as a Medical Device (SaMD), wearables, biosensors, CGM and insulin pumps, and connected device platforms for remote and therapeutic monitoring (RPM and RTM). What separates us is what our customers walk away with. They own the source code, the platform, and the infrastructure it runs on. No lock-in. We work with device companies from early feasibility through Clinical and Commercial milestones, developing the software and its supporting evidence together, so the next milestone is a step forward rather than a remediation project.