ELTON’s Subscription Penetration Testing and Platform-Based Vulnerability Management

ELTON delivers subscription-based penetration testing integrated with its platform-driven vulnerability management solution, ensuring continuous FDA- and globally compliant cybersecurity oversight for medical devices. Unlike one-off reports, ELTON’s methodology—proven across 600+ regulatory submissions—combines PTES/ISSAF standards, threat modeling, automated and manual testing, and advanced vulnerability chaining. Practitioners bring 50+ years’ experience, multiple zero-day CVE disclosures, and FDA-recognized certifications. Testing activities include attack surface, penetration, vulnerability scanning, and resiliency testing, all contextualized using FDA’s MITRE CVSS rubric. Results feed into a living platform that unifies SBOM monitoring, chained exploitability analysis, and audit-ready reporting, enabling manufacturers to meet regulatory expectations efficiently and defensibly.

Why Manufacturers Need More Than One-Off Testing

Medical device cybersecurity is under unprecedented scrutiny. The FDA and global regulators now expect manufacturers to maintain continuous vulnerability management, including periodic penetration testing, SBOM monitoring, and defensible risk rating. Traditional one-time assessments with static PDF reports can no longer satisfy these requirements—or protect against costly audit findings.

ELTON solves this challenge with a subscription penetration testing service fully integrated into our platform-based vulnerability management solution. This approach delivers continuous visibility, regulatory-grade penetration testing, and audit-ready reporting throughout the product lifecycle.

Regulatory-Tested Methodology

ELTON assessments follow the Penetration Testing Execution Standard (PTES) and Information System Security Assessment Framework (ISSAF). Each engagement begins with threat modeling, identifying realistic attack scenarios and potential exploit paths. Testing combines advanced automated scanning with deep manual analysis, focusing on chaining vulnerabilities and bypassing controls to replicate real-world attackers.

Our methodology is regulatory tested across 600+ successful submissions, with all results exportable as regulatory-submittable reports. This ensures FDA, EU MDR, Health Canada, and PMDA alignment without additional lift from your team.

Practitioner Credentials That Regulators Recognize

The FDA evaluates practitioner qualifications when reviewing cybersecurity submissions. ELTON’s team brings:

• 50+ years of combined experience across thousands of device assessments.

• Multiple zero-day CVE disclosures in medical and embedded products.

• Industry certifications: CEH, PenTest+, GPEN, GWAPT, OSCP, CPT.

• Authors of HSCC Joint Security Plan (JSP/JSP2) V&V for medical device cybersecurity.

• Recognized by H-ISAC members as leaders in device and OT security.

• Proven compliance experience with UL 2900, IEC 62443, ISO 14971.

Every assessment is performed by practitioners with 10+ years in medical device penetration testing—ensuring FDA-defensible results.

Testing Activities That Go Beyond the Basics

ELTON’s subscription testing includes the full suite of security activities:

• Attack Surface Testing – Identify misuse scenarios, analyze exposed interfaces, and validate controls.

• Penetration Testing – Human-led testing that chains low-risk issues into real-world exploits.

• Known Vulnerability Scanning – Static/dynamic analysis, CVE scanning, malformed inputs, robustness testing.

• Resiliency Testing – Fuzzing and robustness testing to measure recovery and adaptability.

This broad coverage ensures both known and unknown threats are identified, validated, and contextualized.

Vulnerability Chaining: Beyond One-Off Scores

Isolated vulnerability scores rarely reflect true risk. ELTON overlays penetration test results onto your digital twin, mapping how attackers could chain vulnerabilities into real exploit paths.

• Identifies initial access vectors and privilege escalations.

• Maps bypassed controls and chained exploitability.

• Rates scenarios based on CVSSv3/v4 severity plus product-specific architecture, trust zones, and dataflows.

Instead of guessing, manufacturers get a defensible, scenario-based rating that matches regulatory expectations.

FDA MITRE Rubric Ratings

ELTON applies the FDA-recommended MITRE rubric for CVSS, ensuring findings are consistent with regulatory expectations. Ratings are contextualized using:

• Discovery – Exploits are assumed reusable once discovered; discovery effort does not reduce severity.

• Attack Vector – Distinguishes physical access versus network access, ignoring external firewall protections as per FDA guidance.

• Attack Complexity – Rates whether exploitation is straightforward (LOW) or requires rare conditions or advanced evasion (HIGH).

By combining MITRE rubric scoring with ELTON’s digital twin context, manufacturers receive ratings that are standardized, defensible, and FDA-aligned.

Platform-Based Oversight and Compliance

ELTON’s platform integrates all vulnerability inputs—pentests, SBOM scans, SAST/DAST, fuzzing—into a living vulnerability inventory.

• Continuous updates as new CVEs and patches emerge.

• Audit-ready reports with traceable history of ratings and decisions.

• Portfolio-wide visibility across all releases and legacy products.

• Automated compliance metrics including vulnerability density and time-to-triage.

This eliminates manual report refreshes, reduces duplicated effort, and ensures continuous regulatory compliance.

The ELTON Advantage

• Subscription penetration testing aligned with FDA and global expectations.

• 600+ submissions proving regulatory defensibility.

• Full-spectrum testing (attack surface, pentest, vulnerability, resiliency).

• Vulnerability chaining for real-world prioritization.

• MITRE rubric CVSS scoring for FDA acceptance.

• Living, platform-based vulnerability intelligence.

With ELTON, manufacturers achieve safer devices, smoother audits, and reduced operational burden—while meeting FDA’s demand for continuous cybersecurity oversight.