01
Security Architecture & Threat Modeling
Analysis of device components, interfaces, trust boundaries, data flows, attack surfaces, and credible threat scenarios based on the product’s actual design.
Software Regulatory
& Compliance
FDA submissions, IEC 62304 lifecycle compliance, software audits, and remediation.
Explore capability ↗Medical Device
Cybersecurity
Security risk assessments, threat modeling, SBOMs, testing, and FDA readiness.
Current capabilitySoftware Engineering
Embedded software development, system architecture, debugging, and verification.
Explore capability ↗Product Security
Office
Ongoing, engineering-led cybersecurity oversight across the medical device lifecycle.
Explore offering ↗
MEDICAL DEVICE CYBERSECURITY
Product Security Grounded in How the Device Works.
Effective medical device cybersecurity starts with understanding the product, its interfaces, and its operating environment. InnoRevision connects engineering analysis with security risk management and regulatory evidence aligned with current FDA cybersecurity guidance and, for cyber devices, applicable FD&C Act Section 524B requirements—from early architecture review through premarket submission and postmarket maintenance.
02
Security Risk Assessment & Controls
Evaluation of cybersecurity threats, exploitability, potential impacts, and security measures, with attention to interaction between cybersecurity and patient safety risk management.
03
SBOMs & Software Component Analysis
Creation and maintenance of software bills of materials, component inventories, support status, and applicability reviews for third-party and open-source dependencies.
04
Security Verification & Testing
Planning and technical review of security testing, static analysis, vulnerability assessment, penetration testing, and evidence that security controls perform as intended.
05
FDA Cybersecurity & Section 524B Support
Development and review of cybersecurity management plans, reports, architecture information, threat models, risk documentation, testing evidence, labeling-related content, SBOMs, and technical responses aligned with current FDA guidance and applicable Section 524B requirements.
06
Postmarket Vulnerability & Update Support
Product-specific vulnerability evaluation, coordinated remediation planning, security update considerations, and maintenance of cybersecurity records over the supported product lifecycle.
Get in Touch
Let's Talk About Your Project.
Whether you have a specific software, regulatory, or cybersecurity need—or would like ongoing product security support—we would welcome the opportunity to discuss how InnoRevision can help.
Contact Us by Email ↗