Regulated Medtech & Diagnostics
I've guided FDA De Novo submissions to approval for two medtech diagnostics companies, built a SOC 2 Type II compliance program from scratch, and carried a medtech diagnostics client through its IPO as primary technical lead, native iOS/Android and a NestJS/React web platform, backed by custom Google Cloud data pipelines for data science.
A full breakdown of how I work inside a regulated software development lifecycle, and a named readiness assessment offering, is coming soon. In the meantime, reach out to talk through where your team stands.