01
Product Security Baseline & Annual Plan
Review the product portfolio, cybersecurity documentation, responsibilities, and development practices to establish priorities, scope, cadence, and an annual operating plan.
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.
Explore capability ↗Software Engineering
Embedded software development, system architecture, debugging, and verification.
Explore capability ↗Product Security
Office
Ongoing, engineering-led cybersecurity oversight across the medical device lifecycle.
Current offering
EXTERNAL PRODUCT SECURITY OFFICE
Ongoing Product Security. Connected to Your Engineering Team.
Medical device cybersecurity does not end with a submission or product launch. Through an annual agreement, InnoRevision serves as an external product security lead—operating agreed cybersecurity activities, maintaining supporting evidence, and coordinating with engineering, quality, and regulatory teams while the manufacturer retains product and regulatory decision authority.
02
Vulnerability Monitoring & Evaluation
Maintain a process for reviewing relevant vulnerability information and assessing applicability in the context of specific software components, device architecture, and deployment environment.
03
SBOM & Third-Party Component Maintenance
Support ongoing SBOM updates, component changes, supplier information review, and traceability between identified dependencies and affected products.
04
Product Cybersecurity Risk & Evidence
Keep cybersecurity risk documentation, threat assumptions, security controls, and supporting technical records aligned with product changes and emerging information.
05
Release, Update & Incident Coordination
Work alongside engineering, quality, and regulatory teams as software changes, security findings, field issues, or update decisions require product-specific technical review.
06
Program Reporting & Annual Review
Maintain scheduled status reviews, open-action tracking, management reporting, and an annual assessment of program performance and next-year priorities.
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 ↗