Fixed price, guaranteed outcomes.
We design, build, validate, and FDA-clear your AI/ML software. One team, one timeline, one cleared device.
A guaranteed regulatory plan, clinical evidence plan, and FDA Pre-Sub submitted in four weeks.
Already have the model? We build the V&V evidence, software and cybersecurity documentation, and guarantee your AI/ML SaMD submitted to FDA in three months.
You need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter.
A lean, audit-ready ISO 13485 quality system stood up in two months --- built for SaMD teams, not paperwork.
SENIOR SOFTWARE ENGINEER I
Joined: October 5, 2026
