Email course · 3 parts
FreeThe Clinical-Utility Prompt Sprint
Draft the study that gets your AI device paid — in 3 prompts, over 3 days. One email a day, one prompt each, run in your own AI platform against your own device.
Education
Learn the work, not the theory
Short email courses that walk your team through a piece of regulatory work on your own product — one prompt a day, in your own AI platform. Free, no account, one click to leave. Longer operator-grade cohorts are in build.
Free · in your inbox
Email courses
A few short emails, one prompt each. Each prompt interviews you about your own device, then produces something you can use — a claim, a study skeleton, a change-control envelope. It surfaces your gap in your own words; it doesn't hand you an answer.
Applied Education
Operator-grade cohorts
Practical training that lifts quality and regulatory teams to the standard the work demands — built around ISO 13485, MDSAP, FDA and TGA. For the first eighteen months in a regulated role, and for the people who have to sign.
In build
What a cohort covers
- Building a QMS someone can actually run, rather than one that passes an audit once.
- CAPA and post-market surveillance as a working loop, not a filing exercise.
- Supplier risk, technical files, and what a reviewer is really reading for.