Your team reviewed last week’s FDA recall.
Could you defend the decision six months later?
Medical device RA/QA teams do not lack regulatory information. They lack a stable judgment system — one that turns every signal into a decision record an auditor can still read six months later.
Free. No sales deck. We start with a real FDA or Health Canada signal from the last 14 days that overlaps your device category, then walk through what a defensible decision for that signal actually looks like.
Hero video (28s, silent-first, subtitled)
Placeholder — final asset pending capture of a real FDA recall from the current week. See founder screenshot checklist.
What the 20-minute Signal Review Workflow Assessment actually does
Every RA/QA team handles regulatory signals differently. Some teams have one reviewer who sees everything. Some escalate to a second reviewer for high-risk devices. Some loop in field service, complaints intake, or operations when a signal touches real customer reports. Some have all three and don’t realize it until an auditor points it out.
The assessment helps us — and you — see clearly which shape your team actually has.
In 20 minutes, we walk through a real regulatory signal from the last 14 days that overlaps your device category, and map the path that signal would take through your current process: who sees it first, who decides if it matters, who is responsible for the action, and where the reasoning actually gets recorded.
No deck. No dashboard demo. No sales pitch. 20 minutes on one real signal, and an honest read of where your current workflow helps you and where it quietly exposes you.
Six months from now, an auditor asks one question.
“How did your team decide that last quarter’s Class II recall didn’t affect your product?” There are three ways most teams answer today.
“We discussed it.”
The honest answer for most small RA/QA teams today. The auditor’s follow-up is immediate: show me the discussion. You open Slack. Three messages, half of which are emoji reacts. The auditor writes something down.
A spreadsheet row marked “not relevant.”
Slightly better. Still not a defensible decision chain. The auditor’s next question is what evidence did you weigh? and the honest answer is what we remembered on the day.
A compiled evidence record for that specific signal.
Source signal, relevance reasoning for your device, severity and scope, recommended action with reason, attributed reviewer. Readable in under five minutes. Defensible in any inspection context.
What we look at during the 20 minutes
We don’t arrive with a fixed answer about your workflow. The assessment is how we both find out. Typically we come away with:
- 01The shape of your current signal review flow — single-reviewer, multi-reviewer, escalation-based, or mixed.
- 02A specific workflow gap — the exact point where reasoning gets made but never captured.
- 03A specific traceability risk — the decision your team made that would be hardest to defend in an audit six months from now.
- 04A concrete example of what a defensible, auditor-ready record for that same signal would look like.
Who this is for
RA/QA leads at medical device companies with 10 to 250 employees, with recent FDA or Health Canada exposure, currently running signal review through email, spreadsheets, and Slack. If that’s a fair description of your team, the assessment is built for you.
Every assessment is delivered personally by the founder. No SDR, no analyst handoff, no scheduling ping-pong with a junior rep. If the assessment turns into a paid pilot, the pilot is founder-led too — the same person you spoke to for 20 minutes is the person who walks your team through the signals.
One real signal. 20 minutes. An honest read.
Free. No sales deck. We start with a real FDA or Health Canada signal from the last 14 days that overlaps your device category, then walk through what a defensible decision for that signal actually looks like.