LiveWatch device risk the way clinicians watch vitals

Medical devices,secured by design.One agentic AI platform.

MShield maps every component in your device, scores each new CVE by its clinical impact, and keeps FDA and EU MDR evidence current from R&D through post-market surveillance.

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Aligned to FDA 21 CFR Part 11, EU MDR 2017/745, IEC 62443 and ISO 14971.

FDA 21 CFR Part 11EU MDR 2017/745IEC 62443 zones and conduitsISO 14971 risk managementSBOM in CycloneDX and SPDXSaMD compliance engine510(k), De Novo and PMA packagesContinuous CVE monitoringFDA 21 CFR Part 11EU MDR 2017/745IEC 62443 zones and conduitsISO 14971 risk managementSBOM in CycloneDX and SPDXSaMD compliance engine510(k), De Novo and PMA packagesContinuous CVE monitoring

Clinical scoring

Every finding, scored by what it means for the patient.

MShield watches the exact components inside your deployed device, ranks each vulnerability by clinical impact and maps it to the control your auditor will ask about. Security and regulatory teams work from the same view.

Connected infusion pump fleet Live monitoring

Device risk postureClinical-weighted

0/100

Controlled, trending up

SBOM componentsCycloneDX

Open sourceCommercialCustom

Compliance mappingAuto-mapped

FDA premarket guidance94%

EU MDR Annex I88%

IEC 62443-4-191%

Findings, scored by clinical impact before triageDevice-scoped, not the entire NVD

Component	Finding	CVSS	Clinical impact	Mapped control	Status
openssl 3.0	Known CVE match	7.5	High, therapy interruption	IEC 62443 SR 4.3	Triaging
BLE stack	Pairing weakness	6.1	Medium, data exposure	FDA SPDF	Mitigating
bootloader	Unsigned update path	7.9	High, device integrity	IEC 62443 CR 3.4	Fixed in 4.2.1
busybox	Known CVE match	5.3	Low, no patient path	ISO 14971	Risk accepted

Clinical impact first

A therapy interruption outranks a higher CVSS with no path to the patient.

Device-scoped CVEs

Matched to this device's SBOM, not the entire NVD.

Mapped as it lands

Each finding links to its IEC 62443, FDA or ISO 14971 control.

Illustrative product view with example data.

Outcomes

Security gates that move in days, not weeks.

Automated, evidence-backed gates replace manual review at every phase, without losing the clinical rigor regulators require.

Faster threat modeling

R&D design security gate

Less pre-submission review

Production V&V security gate

Faster CVE triage

Post-market security gate

Lifecycle coverage

From R&D to post-market

Platform

One platform. Every phase. Zero gaps.

MShield's proprietary model brings threat intelligence, compliance automation and lifecycle tracking into one auditable system. Follow a connected infusion pump through it.

Stage 01 of 04Illustrative exploded view of a connected infusion pump

Stage 01

Device data ingestion

Raw telemetry, firmware metadata and component manifests stream in from connected medical devices across the fleet.

The pump separates into the four subsystems MShield inventories, each with its own software bill of materials.

SBOMFirmwareTelemetry

Stage 02

Proprietary risk modeling

CVSS alone isn't enough. MShield overlays patient safety impact, device criticality and regulatory exposure, the ISO 14971 way.

The wireless module and main board turn red: a flaw there can interrupt therapy or compromise the device.

Clinical impactISO 14971HL7 / DICOM

Stage 03

Compliance alignment

Every finding is mapped automatically to the FDA, EU MDR or IEC 62443 control it touches, so every fix is compliance-aware.

Each subsystem picks up the control a reviewer will check, from IEC 62443 CR 3.4 to ISO 14971 risk controls.

Auto-mappingGap analysisControls

Stage 04

Remediation and reporting

Prioritised remediation workflows, audit-ready reports and real-time dashboards go straight to security and regulatory teams.

Fixes ship, evidence is logged and the whole device is covered, ready for a 510(k), De Novo or PMA reviewer.

Audit trailDashboardsWorkflows

Lifecycle gates

Faster security gates.
Stronger clinical assurance.

MShield replaces manual security reviews with automated, evidence-backed gates, cutting weeks from each phase.

Design inputs

Fielded devices

Design and development

Automated threat modeling against IEC 62443 and ISO 14971 replaces weeks of manual architecture review. MShield generates a structured risk register and SBOM from your design artifacts on day one.

Every finding traces to a clinical risk category, not just a CVSS score.

What this gate produces

Threat models generated from design specs
SBOM with component-level CVE binding
IEC 62443 security levels per subsystem
ISO 14971 risk classification pre-populated

Time spent at this gate

faster threat modeling

Manual reviewWeeks

With MShieldDays

Every connection creates another clinical dependency. Point-in-time compliance is no longer enough, because cyber risk is inseparable from patient safety.

Built for hospitals

Built for regulated environments. Not retrofitted.

Hospital networks are flat, legacy and full of devices that can't be rebooted. MShield models them as they are, then enforces the zones and conduits IEC 62443 expects.

Purpose-built for medical devices

Generic security tools miss device-specific attack surfaces. MShield's model is trained exclusively on medical device threat data, so it knows which path reaches a patient and where to stop it.

Attack path from a compromised workstation
Blocked at the clinical zone boundary
Legitimate HL7 and DICOM traffic, allowed

Regulatory alignment by design

FDA 21 CFR Part 11, EU MDR 2017/745 and IEC 62443 aren't add-ons. They are the architecture.

FDA 21 CFR Part 11records and signatures

EU MDR 2017/745Annex I and II

IEC 62443zones and conduits

ISO 14971risk management

Continuous, not point-in-time

Security posture is maintained across the full device lifecycle, not just at submission checkpoints.

MShield continuous posturePoint-in-time audits

Audit-ready at every stage

Every action, finding and remediation is logged in a structured, auditable format.

09:14:02SBOMregenerated for build 4.2.1

09:14:07MAPfinding linked to IEC 62443 SR 4.3

09:15:31RISKclinical impact scored High

09:22:48SIGNfirmware signature verified

09:40:10FIXremediation merged, PR #482

09:41:05EVID510(k) evidence package updated

09:14:02SBOMregenerated for build 4.2.1

09:14:07MAPfinding linked to IEC 62443 SR 4.3

09:15:31RISKclinical impact scored High

09:22:48SIGNfirmware signature verified

09:40:10FIXremediation merged, PR #482

09:41:05EVID510(k) evidence package updated

100%

Lifecycle coverage

Frameworks mapped

Submission paths: 510(k), De Novo and PMA

Solutions

Built for every class of connected care.

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Hardware & kinetics

Robotic Surgical Systems

Zero-trust control paths between console, manipulators and imaging. Secure boot, tamper response and encrypted kinetics, tuned to the real-time loop.

Apps, APIs & cloud

Digital Health

Patient identity, PHI privacy and secure integrations for the companion apps and cloud services around every device.

Software as a Medical Device

SaMD

Secure SDLC, runtime integrity and vulnerability management that resolve straight into submission evidence.

Software in a Medical Device

SiMD

Secure boot chains, firmware hardening, protocol assessment and anti-rollback for embedded platforms.

IntegrationsFits your toolchain

Plugs into the tools your teams already use.

MShield connects to source control, CI/CD, issue tracking and your QMS, so security evidence flows into your submission without anyone copying it across.

Source control: GitHub, GitLab, Bitbucket
CI/CD: Jenkins, GitHub Actions
Issue tracking: Jira, Azure DevOps
Code security: SonarQube, Veracode
QMS: Greenlight Guru, Veeva

SonarQube

Veeva

GitLab

GitHub Actions

Azure DevOps

Veracode

GitHub

Jira

Greenlight Guru

Jenkins

Evidence

The evidence, exactly as your reviewers will read it.

Security architects and regulatory leads want to see real outputs before they sign. Here are sample files for a fictional infusion pump, with a note on what each part is for.

1{
2  "bomFormat": "CycloneDX",
3  "specVersion": "1.6",
4  "serialNumber": "urn:uuid:7c1f0b52-9e4d-4a8e-b2f1-3d6a90c4e118",
5  "metadata": {
6    "timestamp": "2026-09-14T08:42:17Z",
7    "component": {
8      "type": "device", "name": "Sample infusion pump", "version": "4.2.1"
9    }
10  },
11  "components": [
12    { "bom-ref": "fw-ctrl", "type": "firmware",
13      "name": "pump-controller", "version": "4.2.1",
14      "hashes": [{ "alg": "SHA-256", "content": "9f2c7d…e41a" }] },
15    { "bom-ref": "ble", "type": "library",
16      "name": "ble-stack", "version": "5.2.3",
17      "purl": "pkg:generic/example-silicon/ble-stack@5.2.3" },
18    { "bom-ref": "rtos", "type": "operating-system",
19      "name": "rtos-kernel", "version": "10.5.1" }
20  ],
21  "vulnerabilities": [
22    { "id": "CVE-2026-24817", "source": { "name": "NVD" },
23      "ratings": [{ "method": "CVSSv31", "score": 8.1, "severity": "high" }],
24      "affects": [{ "ref": "ble" }] }
25  ]
26}

Illustrative sample for a fictional device. Identifiers, names and scores are invented. Select a note to highlight the lines it explains.

Why the evidence holds up in review

Audit trail

Aligned to 21 CFR Part 11 electronic records requirements, with tamper-evident logs.

Build integrity

Every build artifact is signed and carries an integrity attestation.

Standard formats

SBOMs are generated in CycloneDX and SPDX, the two formats reviewers and tools expect.

Clinical scoring

Every finding traces to an ISO 14971 clinical risk category, not just a CVSS score.

Framework mapping

Findings map to FDA premarket guidance, EU MDR Annex I and IEC 62443 controls, with evidence citations.

Your documents

Files you send for expert review are encrypted in transit and at rest, and handled under NDA.

Demo30-minute live session

See it on your device

See MShield in action.

Request a live demonstration of our proprietary lifecycle security model and see how MShield maps to your device's regulatory requirements.

Your device's threat surface mapped to our data model
The controls that apply to your submission path
Where automated gates save weeks in your lifecycle