Practical tools for QA/RA work

I built these tools from real audits, regulatory work and day-to-day quality management. Use them when you need a second professional lens before you act, but most of all - because I love it.

A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.

Let's talk about your device

• MDR classification (Annex VIII) — Find the risk class of your device under the MDR rules.
• Reporting deadlines — How many days you have to report an incident, by market.
• PSUR frequency — When your periodic safety update report is due.
• 510(k), De Novo or PMA? — Which FDA pathway fits your device.
• EU MDR and FDA, side by side — Compare the requirements side by side.
• quality.plain — Plain-language explanations of quality terms.
• quality.navigator — Interactive guidance for everyday QA/RA situations, such as complaints, CAPA decisions, nonconforming product and audit prep.
• agents. — AI assistants for everyday QA/RA tasks.
• play. — Short games that make regulatory terms stick.