24% of healthcare facilities have been attacked through a medical device.
Black Duck detects the risk — including malware. Siemens Polarion proves it was governed.
and
In medical devices, a vulnerability in open-source software is not a cyber risk. It is a clinical risk.
Of healthcare facilities have experienced a cyberattack on a medical device — up from 22% in 2025. 80% of those attacked reported moderate or significant patient care impact. Source: RunSafe 2026.
Vulnerabilities in Black Duck's knowledge base — with 63,000+ exclusive BDSA advisories not in NVD. BDSA alerts arrive up to 3 weeks ahead of public disclosure.
Of codebases contain license conflicts — the highest rate in OSSRA history. In medical devices, a license violation in a clinical product carries IP and CE marking risk.
Manual handoffs required. X-DLM™ routes Black Duck findings — vulnerabilities, malware, SOUP, license conflicts — into governed Polarion workflows automatically.
Sources: RunSafe Medical Device Cybersecurity Index 2026. Black Duck OSSRA 2026. Black Duck BDSA documentation.
Detection without a governed response trail is not FDA conformity. It is exposure.
- 01
Detect vulnerabilities, malware, and SOUP risk before the FDA finds them
Black Duck scans every component — open source, commercial, AI-generated snippets, binaries, containers, firmware — for vulnerabilities, malicious packages, license conflicts, and SOUP provenance risk. BDSA advisories surface threats up to 3 weeks before NVD publication.
- 02
Govern the full FDA response chain
Every Black Duck finding is routed into Polarion as a governed work item — with IEC 62304 Class assignment, owner, risk acceptance or remediation timeline, legal or QA sign-off, and test verification. Every step is timestamped and auditor-ready.
- 03
Postmarket surveillance evidence — built continuously
FDA Section 524B requires a postmarket vulnerability management plan and ongoing monitoring. X-DLM™ maintains the evidence of continuous monitoring, CVE response, and patch management through Polarion LiveDocs — updated with every build cycle.
- 04
SBOM as a living security artifact
Black Duck generates SPDX and CycloneDX SBOMs from every scan. X-DLM™ version-controls them inside Polarion — linked to every vulnerability decision, traceable to every release, and available for FDA submission, notified body review, or hospital procurement RFP on demand.
See how Siemens Polarion and Black Duck become one governed software risk workflow.
X-DLM™ turns Black Duck software supply chain intelligence into Siemens Polarion work items, requirements links, approvals, escalation paths, and continuously maintained evidence.
Brand authority buyers recognize
Backed by Siemens lifecycle governance and Black Duck AppSec intelligence.
Siemens Polarion ALM
Polarion provides the lifecycle system of record for requirements, tests, approvals, traceability, workflow automation, audit evidence, and regulated software delivery.
Black Duck Software Composition Analysis
Black Duck identifies open source and third-party components across source, binaries, containers, firmware, snippets, AI-generated code, and C/C++ environments without package managers.
What X-DLM™ changes for your business
Security runs itself.Your teams focus on product innovation.
Before
Security as a release bottleneck
Manual triage, fragmented tools, late-cycle surprises. Security gates slow delivery and drain engineering bandwidth.
After X-DLM™
Automated vulnerability handling from detection to remediation. Engineers stay focused on building — security runs in parallel, not as a checkpoint.
Before
Security bolted on at the end
Reactive posture. Vulnerabilities discovered late. Costly rework. Customers and auditors see through it.
After X-DLM™
Secure by design from day one. Black Duck SCA monitors every component continuously — source, binaries, firmware, and AI-generated code — before it ships.
Before
Compliance as recurring overhead
Engineers pulled into audit prep. Legal scrambling for evidence. Weeks of work per assessment. Repeatable cost with no revenue return.
After X-DLM™
Evidence generated and timestamped continuously via Polarion LiveDocs. Audit prep drops 60–80%. What took weeks takes hours — without touching engineering.
Before
Security as a cost story in sales
Enterprise buyers in regulated markets want proof of security maturity. Without it, deals stall, diligence cycles extend, and contracts go to competitors who have it.
After X-DLM™
100% traceable, audit-ready cybersecurity proof — with Siemens and Black Duck behind it. Your sales team closes faster. Your brand commands a premium.
Medical device companies answer to more than one framework — simultaneously.
FDA Section 524B is the floor, not the ceiling. IEC 62304, EU MDR, ISO 14971, HIPAA, and NIST SSDF run in parallel — each with its own evidence requirements, its own submission deadline, and its own consequence for missing components.
View FDA 524B, IEC 62304 & All Regulations →Medical device security evidence that builds itself.
Before the FDA or a hospital procurement team asks.
X-DLM™ connects Black Duck's vulnerability, malware, and SBOM intelligence to Siemens Polarion's governed workflows — so your security team can produce FDA 524B evidence, IEC 62304 SOUP records, VDR/VEX artifacts, and postmarket surveillance documentation on demand.