Free email sprint · 3 days + a bonus
Draft the change-control envelope that lets you update your AI model — without re-submitting — in 3 prompts, over 3 days.
A Predetermined Change Control Plan pre-authorises a bounded set of model changes, so you can improve the device without a new submission. Most teams scope it too narrow (and re-file constantly) or too wide (and see it cut back in review). This sprint drafts yours.
- Three short emails, one prompt each — run in your own AI platform, against your own device.
- You leave with your own PCCP envelope, a reviewer's red-pen list, and the one modification to keep out.
- A fourth, bonus email works the whole sprint end-to-end on a composite device, so you can compare.
- Written by Ross Prior (Saolyn), from The State of AI in Medical Devices 2026 with Kelly Coverdale (Cover Biomedical).
Opening shortly
The sprint isn't open for signup yet. In the meantime, the report it's drawn from is on the reports page.
See the reportWhat the sprint covers
- 1
List the changes you'll actually want
Teams scope a PCCP around the changes they can imagine today, not the ones they'll want. Day one lists every model change you're likely to want over 24 months and sorts each into “could be pre-authorised” or “needs a new submission”.
- 2
Draft the envelope
Each modification with its verification method, its objective acceptance criteria, and the column teams skip — what must not change. Anything without objective criteria isn't envelope-ready yet.
- 3
Stress-test it, then check the EU
Read as an FDA reviewer, then as a notified body. Europe's pre-determined-change route under AI Act Article 43(4) doesn't apply to device AI until 2 August 2028, so the US envelope doesn't travel intact — this is where you find out how far it does.
- +
Bonus: the whole sprint, worked
All three days run end-to-end on a composite AI device, so you can hold your envelope up against one that's been through a reviewer's red pen.