Use Case
Streamline Premarket Approval
Built on a decade of expertise and over 600 regulatory submissions, ELTON delivers proven regulatory submission documentation backed by an
FDA-approved Medical Device Development Tool (MDDT)
Overview
ELTON is the FDA Standard
EELTON streamlines premarket regulatory approvals by aligning with all FDA 2025 cybersecurity testing expectations—including vulnerability chaining—and delivering defensible results powered by an AI Copilot built on the FDA-approved CVSS Rubric. The platform’s methodology is backed by an FDA-recognized Medical Device Development Tool (MDDT), ensuring consistency and regulatory confidence.
Avoid Late-Stage Delays
ELTON integrates vulnerability analysis early in development, enabling each software release to improve security posture, meet FDA expectations for SPDF, and reduce risk well before submission, minimizing late-stage rework and accelerating regulatory approval.
Premarket Approval with Postmarket Readiness
When ELTON is engaged during premarket development, it builds a deep understanding of your product’s architecture, software components, and risk posture well before submission. FDA requirements mandate a Postmarket Monitoring SOP at submission, ELTON ensures monitoring begins early and continues seamlessly, eliminating audit gaps.
Why ELTON
600+ Products Approved with ELTON Assistance
We’ve assisted hundreds of products and interfaced with global regulators in response to questions or concerns around the globe.
ELTON embodies years of hands-on regulatory expertise, bringing deep understanding of what it takes to meet premarket expectations the right way—efficiently, defensibly, and without overburdening engineering teams. By helping manufacturers build more secure designs from the start, ELTON reduces the long-term cost of postmarket maintenance, where vulnerabilities are more expensive to address.
ELTON seamlessly extends the regulatory process into long-term product maintenance without restarting from scratch.
Regulations
ELTON Meets Global Cybersecurity Regulations
Do it right the first time, for all markets
Starting in 2014 the US FDA released premarket guidance for cybersecurity and further introduced an update in 2023 and 2025 with expansive additions. The US FDA released postmarket cybersecurity guidance in 2016 that remains in effect today.
In the EU, 74/2017 (MDR) and 746/2017 (IVDR) called the Medical Device Regulations are requiring all medical devices sold in the EU be recertified to enhanced cybersecurity standards. The Medical Device Coordinating Group (MDCG) provided guidance for meeting the EU Medical Device Regulation (MDR) as it pertains to cybersecurity (MDR MDCG 2019-16).
China (CFDA) Cybersecurity Law (CSL) is the administration of medical devices in China, where as of 2018 medical devices must be assessed for cybersecurity protection under the Principles on Guiding Technology Examination of Medical Device Cybersecurity Registration (CFDA Guidelines).
Japanese regulation stipulates that, in addition to the conformity to the JIS T 2304 (IEC 62304), for medical devices connected to other IT devices and medical devices connected to the Internet, cyber security measures based on JIS T 81001-5-1 (IEC 81001-5-1) are required to reduce cyber security risks to acceptable levels. This new regulation was put into practice on April 1, 2023, with a one-year transitional period until March 31, 2024.
Get Faster Regulatory Approval by Meeting Premarket Guidance
Improper documentation will result in outright rejection
Meet global regulatory expectations the first time with ELTON’s cybersecurity testing and vulnerability management platform, purpose-built to support FDA and international premarket requirements. ELTON executes and documents all necessary cybersecurity activities such as SBOM generation, penetration testing, CVE triage, and risk analysis in the format expected by regulators, reducing the risk of delays or rejections due to missing or incomplete documentation. Unlike traditional services that require costly tools and dedicated teams, ELTON delivers a complete, subscription-based solution that streamlines compliance and reduces overhead for manufacturers and startups alike.
Threat Modeling
Mitigation Development
Vulnerability Analysis
Risk Analysis
Software Composition & Vulnerability Analysis
Software Bill of Materials (SBOM) Generation
Secure Code Analysis
SAST/DAST Scanning
Penetration Testing
Fuzz Testing
Robustness Testing
Security Views of Architecture
Security Verification & Validation
Security Risk Management Reporting
Meet DoD/DHA requirements for Authority-to-Operate (ATO)
The platform’s robust capabilities such as SBOM generation, continuous CVE monitoring, contextual vulnerability scoring, and audit-ready reporting align closely with key ATO expectations, including ongoing risk assessment, vulnerability tracking, and patch planning. By streamlining evidence collection and integrating vulnerability management into the full product lifecycle, ELTON reduces duplication of effort between civilian and military regulatory pathways.
Compliance Insights
Power Your Next Submission with Intelligence
ELTON Copilot is built on insights and data from the field. View more insights
Streamlined Premarket Approvals Start with ELTON
Design, develop, and ship medical devices faster by employing ELTON, backed by an FDA-approved Medical Device Development Tool (MDDT)