Writing

Notes on software quality, regulation & building things people depend on.

Working notes from fifteen-plus years building software where the stakes are real — health, education, and public infrastructure. Some of it is regulation; a lot of it is how good teams ship without cutting corners.

FDA & software quality · CSA · Part 2 of 4 · 2026

CSA Goes Final: What Changed, and Where the FDA Is Headed

What changed when the FDA's Computer Software Assurance guidance went from draft to final — the February 2026 QMSR alignment, and what the guidance actually requires: when production and quality-system software must be validated, and how much.

CSA QMSR ISO 13485 draft → final

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FDA & software quality · CSA · Part 1 of 4 · Written 2022

Software Assurance in Health Tech: An Explainer on the Latest from the FDA

A plain-language walk through the FDA's Computer Software Assurance (CSA) approach: how to calculate the risk a piece of software poses to patients, right-size your assurance effort to that risk, and document it — so validation focuses effort where it's most needed instead of drowning teams in paperwork.

CSA 21 CFR Part 11 risk-based validation health tech

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Still to come in this series — the surrounding regulations in context, and an informed critique — plus notes on agentic development and continuous compliance. In the meantime, see the Coach Rob case study or say hello.