Knut is an AI teammate for medical software companies. He joins your Slack or Teams, keeps your design history file current, chases the overdue CAPAs, and answers “do we need a 510(k) for this?” — with the clause to prove it.
Already on the team at
In a medical software company, the answers you need live in your QMS, GitHub, Jira and a hundred documents. Finding them is slow. Compliance work is manual. Audit prep eats weeks. And when someone leaves, their knowledge walks out with them.
You don’t need another dashboard. You need someone who already knows.
Knut was built for one job: regulatory affairs for software as a medical device. He’s calm, methodical, and mildly obsessive about citations — the expert you’d otherwise rent by the hour. No retainer, no scope-of-work, no waiting three days for an email back.
“I’ve read every revision of ISO 13485 since 2003, and I remember all of them. Ask me anything — the worst I’ll ever say is ‘it depends,’ followed by the exact clause it depends on.”
No dashboard, no training course. He works in the channels your team already argues in.
Invite him like any new hire. He shows up with a profile, a status, and good channel etiquette — no new tool for anyone to learn.
Connect your QMS and your docs. He learns your intended use, quality system, and target markets, maps the clauses that apply to you — and finds the gaps before an auditor does.
He doesn’t wait to be asked. He drafts the records, chases the overdue CAPAs, flags new guidance that touches your product, and answers the hard questions in-thread — every claim cited.
Read-only, scoped, and reversible. Every answer cites the record it came from.
Connected to your QMS and grounded in the applicable standard — with citations your auditor can follow.
Knut doesn’t look these up — he knows them. The clauses, the deliverables, and how one requirement quietly triggers three more.
Design controls, submission strategy, and Letter-to-File vs. 510(k) decisions.
CAPA, management review, supplier controls, and audit readiness end to end.
Safety classification, SOUP management, and lifecycle records that hold up.
Safeguards, BAAs, and breach-response readiness for PHI-handling systems.
Technical documentation, clinical evaluation, and post-market surveillance.
Control mapping and evidence collection to satisfy enterprise buyers.
“We cut our 510(k) prep from months to weeks. Knut drafts, my team reviews. Nobody stares at a blank page anymore.”
“Our consultancy invoices dropped to almost nothing. Knut answers in thirty seconds what used to be a $600 email — and our engineers actually ask him questions now.”
“We walked into our ISO 13485 surveillance audit with zero surprises. Knut had flagged every gap weeks in advance.”
Your regulatory data is among the most sensitive you hold. Knut treats it that way.
Roughly half the cost of a compliance hire — working 24/7, fully documented, every answer sourced.
For the day-to-day work, yes — the drafting, the tracking, and the “quick questions” that used to run up hourly invoices. Knut answers in seconds and the knowledge stays in your workspace. For high-stakes strategy, he makes your experts dramatically faster — and your team stays in control of every decision.
Your data is never used to train models. It’s encrypted in transit and at rest, accessed under least privilege, and handled under SOC 2-aligned controls with data-residency options for EU and regional needs.
Adding Knut takes minutes, and he’s useful the same afternoon. Connect your QMS and over his first week he absorbs your product context and quality system — his answers get sharper, and he starts flagging things you didn’t ask about.
FDA QSR (21 CFR 820) and 510(k), ISO 13485, IEC 62304, HIPAA, EU MDR, and SOC 2 today — with new frameworks added regularly. If a standard applies to medical software, it’s on our roadmap.
Yes — full parity across both. Knut joins as a member, responds in channels and threads, and posts interactive record cards in whichever tool your team already uses.
No. Knut drafts and recommends; your quality team approves. Every action is logged and every claim is traceable to a source, so you keep a complete audit trail.
Book a 30-minute call and watch Knut work, connected to a sandbox of your systems — in your own Slack or Teams.
Book a call