Company & Product Profile
The master record that makes the software contextual, not just a pretty agenda.
BaiOS · Venture planning for medtech
Business planning for medical device startups.
BaiOS turns a device programme into a living plan — design controls, clinical evidence, the conformity route, runway and European funding in one place. Not task management: the system that prices the next milestone before you commit to it.
The problem
A device that works, and a plan that stops at the CE mark.
MDR made the evidence heavier and the timeline longer. Most seed-stage plans still price the old one. A spreadsheet does not know that your risk class decides your burn. BaiOS does.
01
No operator on the plan
The founder runs engineering, funding and the board update alone, with no CFO, no PMO and no regulatory or quality lead.
02
Two clocks, one model
First revenue and the next round are different dates with different requirements, and the financial model only has room for one of them.
03
Design controls priced as paperwork
The ISO 13485 design record, the ISO 14971 risk file and — for software — IEC 62304 are engineering months with a cost. They are budgeted as documentation.
04
The class decides the company, and it is decided late
A Class IIa path and a Class III path are two different companies with two different burns. Classification is treated as a formality until it is not.
05
Clinical evidence arrives as a shock
Clinical evaluation is mandatory for every class, and claiming equivalence to an existing device is far harder than it used to be.
06
European funding is a maze
CDTI, ENISA, EIC, Eurostars, equity and loans — each with its own timing and eligible costs — planned in disconnected spreadsheets.
Milestone-to-Money
How BaiOS connects the gate to the money.
The gate ↔ money relationship is the soul of the product. Change one assumption and the runway, the gates and the funding gap move with it.
Map the product
One master record — company, product, intended use and a living product profile — so the plan is contextual, not a pretty agenda.
Sequence the gates
Decision gates, not tasks: each carries minimum criteria, evidence, cost, date, dependencies and a RAG status.
Price each milestone
Every milestone is linked to a cost and to the funding it unlocks. "What if the notified body takes two quarters longer?" is answered in seconds.
Track the runway
Burn-to-milestone and cash-out date, with the revenue line your plan actually has — a runway that knows what a gate is, recomputed server-side.
Report from the model
The investor update, board pack and CDTI/ENISA report fall out of the same plan. The PDF comes out of the model.
Design verification
Design controls
€210K
▲ on track
Clinical evaluation report
Clinical evidence
€95K
● pending
Notified body audit
Regulatory · MDR
Apr '27
▼ 6 wks
Seed close
Investment
€1.8M
▲ on plan
The engine
Milestone to money, in one chain.
Anyone can tell a founder they have twelve months of cash. The useful sentence names the next milestone, what it costs and what unlocks it. Change one assumption and the runway, the gates and the funding gap all move with it.
The living plan
MilestoneGate criteria · Evidence
CostPrice per gate · Dependencies
RunwayBurn-to-milestone · Cash-out
FundingGrant · Bridge · Round
Modules
Ten modules, one connected model.
Nothing here is independent: a change in the intended use moves the cost, the timeline, the risk and the story with it.
Development Roadmap
A development roadmap you build against your own conformity route, every step costed and dated.
Regulatory Gates
The differentiator: decision gates you define for your pathway — criteria and go/no-go, not a task list.
Living product profile
Intended use and performance claims kept alive, not a dead PDF — the base of every assumption.
Financial Plan & Runway
Beyond cash in, cash out: burn-to-milestone and cash-out date.
Mixed Funding Planner
Equity, grants, loans and BD in one place — the European non-dilutive map US tools ignore.
Scenario Planning
Every assumption automatically impacts cash, milestones and reporting.
Investor & Board Reporting
Investor update, board pack and grant report generated from the data model.
Risk Register
Living risks with runway impact, not a forgotten table.
Adbaio Advisor Layer
Expert judgement embedded in the product: comments, monthly review and next best action.
Positioning
What BaiOS is not.
Every alternative owns one slice of the problem. BaiOS ties gate ↔ money together, with European funding logic and Adbaio advisory built in — which none of them have.
01
Not an eQMS
Greenlight Guru and Qualio hold the quality record beautifully. Neither prices your plan, and neither knows how much runway the next design freeze buys.
02
Not a requirements tool
Jama Connect and Matrix Requirements trace requirements to tests. Traceability is not a company plan.
03
Not Asana with a lab coat
Task tools (Asana, Notion, Monday) have no device logic: no gates, no product profile, no runway that knows what a milestone is.
04
Not an FP&A app
Runway and Pigment don't know what a clinical evaluation costs, or that revenue and the next round are two different clocks.
05
Not US-only
The venture tools built for this market ignore MDR and ignore European public funding entirely.
BaiOS + Adbaio
The software keeps the plan alive. The advisor keeps it right.
Adbaio without BaiOS is a great plan that goes stale in a PDF. BaiOS without Adbaio is eighty empty fields a founder abandons. Together they are a living plan with expert judgement embedded in it — the software retains, the advisory reviews it monthly.
Pricing
One workspace, priced by how far you plan.
Monthly, no lock-in. Prices exclude VAT; 21% is added at checkout for Spanish buyers.
Basic
€220/mo
- One company workspace
- Milestone & runway planning
- Email support
Advanced
€280/mo
- Everything in Basic
- Scenario modelling
- Funding & gate tracking
Pro
€390/mo
- Everything in Advanced
- Advisor collaboration
- Board-ready reports
- Priority support
Your living device plan — evidence, regulation and money in one place.
From a working prototype to the next financeable or revenue-generating milestone. Set it up before you pitch, not after: the deck and the data room come out of the model.