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MedTekOSTry the sandbox
Live AI grounded in your evidence

The operating system for medical device companies.

From first prototype to FDA clearance to Series A. One platform. Regulatory authoring, investor data rooms, and live AI grounded in your data. Built for medtech teams that ship.

Try the sandbox →Ask the agent
HIPAA21 CFR Part 11SOC 2 Type IIIEC 62304
os.medtekos.com / compass / 510k

Predicate analysis

K231445

conf 0.984

Substantial equivalence

Drafted

conf 0.967

Cybersecurity bill

SBOM-ready

conf 0.973

Live · grounded in regulation

Ask anything about FDA submissions.

This is the actual MedTek OS agent. Same engine that drafts your 510(k), reasons over your evidence, and refuses to ship below confidence threshold. Test it. Cite-check it. Break it.

Public preview · ungated · rate-limited · phase 1 grounding via RIG

Three jobs. One platform.

What used to take five vendors and a year now takes one platform and a quarter.

Regulatory

Submission-grade authoring.

Compass drafts 510(k), De Novo, IDE, Pre-Sub, IEC 62304 SDP, ISO 14971 RMF, and EU MDR/CER content with a confidence gate that blocks output below 0.97.

Intelligence

Live AI on your evidence.

BrainOS synthesizes your trials, predicates, and prior art into briefings that actually cite. RIG enforces validity windows so stale claims never ship.

Capital

Series A in a click.

InvestOS hydrates a complete data room from your platform: cap table, financial model, regulatory roadmap, IP portfolio, clinical roadmap. Investor-grade.

Platform

Eight modules. One graph. Every artifact a regulated medtech company ships.

All modules read from a single Regulatory Intelligence Graph (RIG) with confidence gates, validity windows, and HMAC-chained audit. Nothing drafts from stale data. Nothing leaves the platform without a citation chain.

01

Compass

Regulatory authoring

Drafts your next 510(k) overnight. Pulls predicates from openFDA, builds substantial-equivalence tables that survive a reviewer's pen, and refuses to ship a section below 0.97 confidence with the citation chain attached. The same engine runs De Novo, IDE, Pre-Sub, IEC 62304, and EU MDR. Reviewers see finished pages, not blank templates.

02

BrainOS

Synthesis + chairman briefs

Reads everything you have ever uploaded and answers like a chief of staff who paid attention. Trial protocols, predicate decisions, internal memos, board decks, patent files. Ask once, get a cited answer, and watch it refresh the moment a source it depended on changes.

03

InvestOS

Data room + investor CRM

Hydrates a Series A data room from your platform on demand. Cap table, financial model, regulatory roadmap, IP portfolio, clinical timeline. Every line tied to a source you can show a partner without flinching. Investors see a company that ships, not a deck that hopes.

04

PatentOS

FTO + claim mapping

Reads 76 million patents and tells you whether you can ship. Maps your claims to prior art with USPTO-grade rigor, flags freedom-to-operate risk before due diligence finds it, and turns a 90-day attorney retainer into a 4-hour deliverable. With a record of every reasoning step.

05

GrantOS

NIH SBIR + EU Horizon

Writes the Aims, the Approach, and the Significance with the eligibility math already done. Knows the difference between an SBIR Phase II and an STTR, between Horizon Health and EIC Accelerator, and will not let you submit a proposal that misses the call's review criteria.

06

PulseOS

Cross-product search

One query reaches every artifact you have ever produced inside the platform. Regulatory drafts, patent claims, trial outcomes, board emails, expense lines. Answers arrive with the document, the page, the version, and the date the source was last verified.

07

ClinicalOS

Protocols + safety

Generates IRB-ready protocols with primary endpoints that satisfy your statistician on the first read. Tracks adverse events on the FDA timeline, raises MedWatch triggers automatically, and keeps your DSMB packet current without anyone copy-pasting from yesterday's spreadsheet.

08

FinOS

Budgets + actuals

Burn, runway, and category variance from a single source of truth that does not depend on a spreadsheet your CFO patched at 2 AM. Reads QuickBooks, projects 18 months on real assumptions, and tells board members exactly what they need to know before they ask.

FDA Tracker · public · free

Every ablation 510(k), the moment FDA posts it.

Live from openFDA, refreshed daily. Defaults to ablation devices. Switch to catheter, surgical, imaging, or all medical devices on the full tracker. Drop any clearance into Compass as a predicate candidate.

510(k)
Sponsor
Class
Cleared
K253771
Nanjing Devin Medical Technology Co., Ltd.
II
2026-03-02
K252632
Nanjing Dewen Medical Technology Co., Ltd.
II
2026-03-02
K251802
Merit Medical Systems, Inc.
II
2026-02-13
K253915
Erbe Elektromedizin GmbH
II
2025-12-18
K252388
Francis Medical, Inc.
II
2025-11-26
Open the full tracker →live · openFDA · refreshed daily

Customer · AblaView

A Class II cardiac ablation device, on track to FDA and Series A. On one platform.

AblaView builds polarization-sensitive OCT guidance for cardiac ablation. They chose MedTek OS as the operating layer for their entire pre-market: regulatory authoring, IP portfolio, clinical protocol, and the Series A data room. One graph. One source of truth. One audit trail.

Read the build log →

$175M

Series A target on platform

97.3%

Confidence on first 510(k) draft

9 mo

Prototype to FDA-ready submission

1

Source of truth for the data room

Trust

Built for regulated medtech from the first commit.

Tenant isolation via Postgres row-level security. AES-256-GCM at rest. TLS 1.2+ in transit. Tamper-evident audit log with HMAC chaining and 6-year retention. BAA available.

HIPAA

PHI, BAA, audit chain

21 CFR Part 11

Electronic records + signatures

SOC 2 Type II

Annual third-party audit

IEC 62304

Software lifecycle aligned

ISO 14971

Risk management

FDA 524B

Cybersecurity SBOM

Sandbox · 14 days · no card

Paste your email. Be inside the platform in 30 seconds.

We provision a guest tenant on os.medtekos.com with sample regulatory evidence and an unlocked agent. Bring your own data when you're ready.

PHI-isolated guest tenant · auto-expires day 14 · BAA on request