For Health and Medtech Startups
Your AI employee crew.
Role-based AI employees for regulatory, quality, research, business intelligence and content. They do the work, report to you and propose; nothing is sent, filed or published without your approval. The crew runs locally and uses your own key, so your sensitive data stays on your machine. We at Serteser Danismanlik set it up and support it.
How it works
The machine prepares, the human approves.
Reports and proposes
Each employee does a bounded task and leaves you a dated report. It is not an autonomous decision-maker; accountability stays with the founder.
You are the gate
Every outward step, sending, filing, publishing, granting access, goes through your approval. In a regulated field this is a safety feature.
Your data stays with you
The crew is local-first and uses your own Claude or Anthropic key. We do not host your regulatory or clinical data; it stays on your machine.
The crew
You switch on the employees you need.
The roles are a library; you enable the ones your startup needs. They all report and propose, the decision is yours.
Regulatory
MDR, FDA and TITCK gap analysis; intended-use statements and classification drafts (Annex VIII Rule 11, MDCG guidance). It prepares the possible readings, it does not declare the class; the decision is yours.
Quality
Document skeletons, traceability matrices and gap lists for ISO 13485, IEC 62304 and ISO 14971. Helps you build QMS habits early.
Research and Intelligence
Competitor, regulatory, literature and grant sweeps. Findings arrive in a sourced, confidence-flagged report; no fabrication.
Business Intelligence
Market sizing, unit economics, competitive positioning, KPIs and ranked options at decision forks. Turns data into decisions, leaves the decision to you.
Content
Thought-leadership, SEO and GEO content, technical-file drafts and external communication, in a measured voice that avoids over-claiming. You publish.
Fundraising
Investor research and matching, investor memos, due-diligence prep and data-room content lists. Every number that reaches an investor goes through your approval.
Software and QA
Code and security audits for startups with software. It only reports and proposes fixes; it never touches the code or ships anything to production.
BD and Outreach
Pipeline tracking, message and follow-up drafts, call briefings. Nothing is sent without your approval.
How it works
A team you own, not a subscription.
The setup is one-time. We configure the crew to your startup, install it on your own machine, and hand it over. It runs on your own Claude or Anthropic key, so there is no per-seat SaaS bill and your regulatory and clinical data never leaves your laptop.
You pay once for the software, the setup, and the medtech expertise behind the roles. Model usage goes straight to your key, at cost, with nothing hidden. Ongoing tuning and new roles are optional, added month to month only if you want them. We start with a short call to scope what fits.
First step
Let's talk about your crew.
A free 15-minute intro. We listen to what you need and scope which roles and setup fit your startup.