25+ years in Healthcare and Life Sciences
U.S. - Led engagements, global delivery
Aligned to FDA 524B, ISO 14971, IEC 62304 and IEC 81001-5-1
25+ years in Healthcare and Life Sciences
U.S. - Led engagements, global delivery
Aligned to FDA 524B, ISO 14971, IEC 62304 and IEC 81001-5-1
Connected medical devices continue to evolve long after launch. A single software release can change a device’s security posture, its validation evidence and its regulatory record at the same time.
Expectations have risen accordingly. FDA may refuse to accept a cyber device submission that lacks a threat model, a software bill of materials, security testing or a postmarket plan. The Quality Management System Regulation, in effect since February 2026, brings security records within the scope of inspection. Health system security teams now require the same evidence before purchase.
Security addressed late, by a separate team, in the weeks before submission no longer meets this standard. Leading manufacturers are building it into engineering and sustaining it across the life of the device.
Submissions that meet FDA's cybersecurity content expectations at intake
Prompt, consistent responses to hospital security reviews
A prioritized remediation plan, carried through by engineers
Security records that reflect the device as built and shipped
A defined, documented response to vulnerabilities after launch
Submissions that meet FDA's cybersecurity content expectations at intake
Prompt, consistent responses to hospital security reviews
A prioritized remediation plan, carried through by engineers
Security records that reflect the device as built and shipped
A defined, documented response to vulnerabilities after launch
Security engineering and documentation are delivered together, by the same team. Every threat, requirement, control, test and software component is connected, giving reviewers a clear line of sight and product teams full visibility into the impact of every change.
Device, documentation and software components evaluated against current FDA expectations and recognized standards
Prioritized roadmap
Threat modeling and security requirements, integrated with the ISO 14971 risk file.
Requirements traceable to risk
Code and firmware remediation, penetration testing, fuzzing and a complete SBOM.
Verified fixes and test evidence
Evidence structured to current FDA guidance, with support for hospital security reviews.
Submission-ready documentation
Continuous vulnerability monitoring, triage, patch planning and verification.
An auditable record of every update
EZEN develops medical device software and firmware. Findings are not simply handed over. They are remediated, tested and documented by the same team, in step with how the product is designed, built and released.
Discovery, feasibility and product roadmap
System and software architecture
Technology and platform selection
Interface, data-flow and release planning
There is no proprietary platform to license, integrate or validate. EZEN works within the established quality system, tools and procedures, so progress begins immediately rather than after a lengthy implementation.
Embedded applications, firmware and device-control software
Drivers, middleware, sensors and instrument integration
Hardware-software integration, diagnostics and logging
Performance, reliability and update mechanisms
Every engagement is led by senior U.S.-based specialists who remain with the program from start to finish, supported by global delivery capacity that scales ahead of submission deadlines.
Clinical workflow and user research
Touchscreen, workstation and device-panel interfaces
Data, image, alarm and status visualization
Usability risk-control implementation and GUI verification
Each threat is scored, recorded in the ISO 14971 risk file and traced through requirements, design and verification, providing a complete and reviewable chain of evidence.
Discovery, feasibility and product roadmap
System and software architecture
Technology and platform selection
Interface, data-flow and release planning
AI accelerates analysis such as SBOM triage and document review. Its role is clearly defined, its outputs are verified by qualified engineers, and nothing enters a regulatory file without human approval.
Embedded applications, firmware and device-control software
Drivers, middleware, sensors and instrument integration
Hardware-software integration, diagnostics and logging
Performance, reliability and update mechanisms
The discipline of a large manufacturer's security program, scaled to the product, the timeline and the team.
Clinical workflow and user research
Touchscreen, workstation and device-panel interfaces
Data, image, alarm and status visualization
Usability risk-control implementation and GUI verification
The two-week Cybersecurity Evidence Sprint delivers a clear assessment of the device and its documentation, with a prioritized plan to close the gaps.
Engagements range from a single service to full lifecycle coverage. Each pairs the engineering work with the evidence to support it.
Evaluation of the device, development process and documentation against FDA expectations, QMSR and recognized standards.
Gap report and prioritized roadmap
Analysis of architecture, data flows, connected applications and cloud services to identify attack paths. Each threat is scored and linked to the ISO 14971 risk file.
Threat model, attack-surface map, security risk assessment
Security requirements defined early, when they are least costly to implement, and traced from design input to verification.
Security requirements, architecture recommendations, traceability matrix
Code and firmware review, followed by remediation of the issues identified.
Review findings and remediated code
Penetration testing, fuzzing, and static and dynamic analysis, each mapped to a security requirement.
Test protocols, reports and remediation evidence
A complete software bill of materials in CycloneDX or SPDX, assessed for known vulnerabilities and exploitability, and maintained with every release.
SBOM, VEX assessment, continuous monitoring
Assessment of AI-specific threats, including training-data tampering, model manipulation and adversarial inputs, integrated into the threat model and test plan.
AI threat assessment, controls and test evidence
Engineering evidence organized to current FDA guidance and prepared for submission.
Submission-ready cybersecurity package
Preparation of the MDS2 forms, security questionnaires and SBOM disclosures that health systems require during procurement.
Completed MDS2 and customer security documentation
Monitoring, triage, impact assessment, patch planning and verification, supported by a coordinated vulnerability disclosure process.
Postmarket plan, triage records, verified updates
Risk assessment and compensating controls for devices already in clinical use, with a practical update roadmap.
Legacy risk assessment and compensating-controls plan
Every engagement is aligned to the regulations and standards applied by FDA, EU authorities and health system security teams.
Cybersecurity requirements for cyber device premarket submissions, including an SBOM and a postmarket vulnerability plan.
Complete submission content: threat model, SBOM, test evidence and postmarket plan.
Expectations for a secure product development framework, SBOM management and vulnerability handling after launch.
Evidence organized to the current guidance, section by section.
The quality system in which cybersecurity design controls, risk and supplier records are maintained and inspected.
Security records structured to fit the quality system and design history file.
Medical device risk management, including security risk.
Each security threat linked to the risk file.
The software lifecycle and the security activities that accompany it.
Security activities integrated without rebuilding the existing process.
Security risk management and postmarket security management.
Applied to the security risk assessment and postmarket process.
Cybersecurity requirements for devices placed on the EU market.
Evidence mapped so one body of work supports both markets.
The standard disclosure form used by health systems to review device security.
Completed accurately from the device evidence.
Security frameworks, testing standards and vulnerability databases.
We use them to shape the security risk assessment and your postmarket communication.
Disclaimer: EZEN does not guarantee clearance, approval or any specific regulatory outcome. EZEN supports the preparation of cybersecurity evidence for regulatory review. Decisions rest with the regulator.
Engineering leaders
Regulatory and quality
Product and commercial
Executive leadership
FDA may refuse to accept it, returning the file before substantive review begins. A gap assessment ahead of submission identifies and closes these issues in advance.
Typically an SBOM, a completed MDS2 form, security documentation and patching commitments. Prepared in advance, these materials keep procurement on schedule.
Most device software includes open-source and third-party components, and the manufacturer is accountable for each one. An SBOM identifies every component and shows which known vulnerabilities can affect the device.
Devices often remain in service for a decade or more. EZEN establishes the monitoring, triage and update process and can operate it alongside the manufacturer’s team.
Since February 2026, FDA’s Quality Management System Regulation has incorporated ISO 13485. Cybersecurity records sit within design controls and risk management and are subject to inspection. EZEN prepares them to fit the existing quality system.
Yes. AI introduces risks such as training-data tampering and model manipulation. These are addressed in the threat model, the test plan and the documentation.
No. EZEN works alongside engineering, regulatory and quality teams, adding capacity and specialist expertise. Design and submission decisions remain with the manufacturer.
EZEN is engineering-led: issues are fixed, not only reported. Senior specialists remain with each program, work is carried out within existing tools, and teams are sized to the device and the deadline
Yes. Additional testing and documentation capacity can be deployed to meet fixed dates. The Evidence Sprint is the fastest route to a clear plan.
No responsible provider can. EZEN helps prepare complete, well-organized cybersecurity evidence aligned to current FDA guidance. Clearance decisions rest with FDA.
Share the device, its stage of development and the target submission date. An EZEN specialist will respond with an initial view of readiness and recommended next steps.