Continuous cyber posture
for medical devices.
Korvantis runs an agentic closed loop across SBOM drift, audit-trail integrity, and FDA pre-market / post-market checks — and loops in a human reviewer only when a finding crosses recall-grade.
Built for 50–500-person MDMs — priced for day-one adoption by a single-Argon-sized manufacturer, not just Strykers and Medtronics.
Representative agent output · rotating signal every 2.2s
The platform
One posture dashboard, anchored to active submissions.
Designed for MDMs that lack dedicated cybersecurity staff but face the same regulatory bar as the largest device makers. Your 510(k), DHF, and post-market surveillance records are the source of truth — every signal, every evidence package, every attestation ties back to them.
Continuous, not quarterly
A managed subscription. The agents re-scan every 4 hours; the dashboard is what your VP of IT and your Quality lead see every morning.
Evidence on the artifact
No “rebuild it for the auditor.” Each finding carries a hash, a timestamp, and the exact DHF row or 510(k) line it ties back to.
Quarterly attestation
A signed package a regulator can read without translation — generated from the same evidence store the agents have been writing to all quarter.
The closed loop
Five agents. One evidence store.
A human, only when it matters.
Routine findings close themselves with the evidence attached. A senior reviewer receives the package, the affected DHF, and a draft notification only when the threshold is FDA-reportable or recall-grade.
- 01
SBOM drift
Every component, on every active device fleet, re-hashed against the canonical SBOM. Drift and unaccountable binaries surface in minutes, not in the next quarterly review.
- 02
Audit-trail integrity
Tamper-evident logs anchored to write-once storage, with hashes that survive a regulator’s read-only spot-check. No retroactive edits, no missing CONTROLS.md rows.
- 03
FDA · 524B + postmarket
Pre-market submissions, the February 2026 postmarket guidance, and Section 524B cybersecurity controls checked against the device’s active submission state — not a generic checklist.
- 04
CISA KEV pre-screen
Every vulnerability is checked against CISA KEV before you ever see it. Reachability is model-checked against the device’s actual surface, not its datasheet.
- 05
Human-loop only on recall-grade
Routine findings close themselves with evidence attached. A senior reviewer is briefed — with the evidence package, the affected DHF, and a draft notification — only when the finding cross an FDA-reportable or recall-grade threshold.
Compliance coverage
Pre-mapped to the controls auditors actually read.
Evidence packages tie to specific design controls, not a generic “we do these things” narrative. Ready for both your U.S. 510(k) pipeline and EU MDR / IVDR convergence.
Cybersecurity in medical devices
Pre-market threat modelling, SBOM submission, vulnerability handling plan, and post-market monitoring anchored to a specific 510(k).
Postmarket cybersecurity guidance
14-day reportability window, cumulative signal review, and remediation cadence checked against the surveillance record.
Known exploited vulnerabilities
Pre-submission screening against KEV. Reachability evidence is generated against the device, not the upstream package.
Annex I cybersecurity convergence
Pre-mapped control libraries for EU MDR/IVDR convergence, with evidence packages tied to specific design controls.
Replace the patchwork
Retire the point-tool stack.
Most MDMs run three to seven point tools and stitch together evidence by hand. Korvantis replaces the lot with one posture service — same posture, one evidence store, one quarterly package.
- Devices monitored412 components / 11 fleets
- Highest CVSS over Q7.8 · not reachable
- KEV hits (Q)0
- FDA-reportable0
- Audit-trail integrity100% · write-once hash
- SBOM re-scans188 over Q (every 4h)
- Human review hours3.5 (Q)
- Controls attested47 / 47
- MDR Annex I gap0
- Artifact hash chainverified
FAQ
What IT and Quality ask first.
The questions we hear most from the second call onward.
Status
Posture your next 510(k)
without a dedicated cyber team.
Tell us the fleet, the active submissions, and the regulator on the calendar. We will reply with a posture briefing and a sample attestation package.
We do not sell or share your fleet inventory. Contact · korvantis@polsia.app
- Tenant isolationper-fleet evidence store
- Audit trailwrite-once hash-anchored
- Evidence provenanceevery signal → DHF row
- Reportable thresholdconfigurable per submission
- Data residencyU.S. and EU mirrors
SBOM ingest
Upload a device SBOM. We do the rest.
Open the device workspace to upload an SPDX or CycloneDX JSON. We parse, store the raw blob, and surface the components on the device page — no CLI, no proprietary schema.
Device workspace
List your monitored devices, inspect their current component set, and upload a fresh SBOM. The latest upload wins — the new file overwrites the prior component list and writes its raw blob to the storage seam.