Get Certification-Ready Without the Last-Minute Scramble
We combine regulatory expertise with platform-native workflows so certification readiness is built continuously, not assembled at the deadline. This is not paperwork assistance. It is structured readiness grounded in shipped software, verification evidence, and traceable decisions.
Why Certification Efforts Break Down
Certification delays rarely come from a single missing document. They come from structural gaps:
Evidence exists, but is scattered across tools and teams
Requirements are interpreted differently by security, engineering, and compliance
Verification results are not clearly tied to shipped artifacts
Changes late in the release cycle invalidate earlier work
The result is rushed remediation, rework, and avoidable submission risk.
Our Certification Accelerator Approach
We help teams move from reactive documentation to continuous certification readiness by anchoring requirements, verification, and evidence to real product artifacts.
Standards Translated into Executable Expectations
We work with your regulatory scope and target standards to clarify what must be demonstrated.
This includes:
- Interpreting regulatory and standard requirements such as FDA guidance, EU CRA, ISO 21434, and IEC 62443
- Breaking high-level clauses into concrete, testable expectations
- Identifying acceptable forms of technical proof versus narrative justification
- Aligning expectations across security, engineering, and quality teams
This eliminates ambiguity early, before it turns into submission risk.
Evidence Grounded in Shipped Software
Certification evidence must reflect what actually ships, not theoretical design intent.
We help ensure evidence is derived from:
- Shipped firmware and binaries
- Verified security controls and configurations
- Test and verification results tied to specific builds
- Traceable risk decisions and mitigations
This creates defensible artifacts that hold up under regulator and auditor review.
Verification That Supports Submission
We help define and implement verification strategies aligned to certification expectations.
This may include:
- Mapping requirements to specific verification methods
- Identifying gaps where testing, analysis, or review is required
- Ensuring verification results are captured as reusable evidence
- Validating that verification remains current as builds change
Verification is treated as a first-class input to certification, not an afterthought.
Supported Certification and Regulatory Contexts
Engagements are scoped to your product category, market, and regulatory obligations. Common contexts include:
FDA premarket and post-market cybersecurity expectations
EU Cyber Resilience Act readiness
ISO 21434 and IEC 62443 certification preparation
Customer and OEM security assurance requirements
Ask about others — we track evolving schemes & harmonized standards.
What You Receive
Clear interpretation of applicable certification requirements
Traceable mapping from requirements to shipped artifacts and evidence
A submission-ready evidence set that remains usable across releases
Regulatory Deadlines Are Imminent.
Are You Ready?
Who Benefits From Certification Acceleration
Product teams approaching first-time certification
Organizations entering new regulated markets
Security and quality teams responsible for submission readiness
Leaders seeking predictable timelines and reduced certification risk
Move Beyond Pass/Fail PDFs
| FeatureFeature | Traditional LabTraditional |  |
|---|---|---|
Binary/firmware decompositionBinary/firmware decomposition | ||
Comprehensive SBOM generationComprehensive SBOM generation | ||
Continuous monitoring (not point-in-time)Continuous monitoring (not point-in-time) | ||
Automated remediation guidanceAutomated remediation guidance | ||
Integrated developer workflowsIntegrated developer workflows | ||
Multi-framework compliance (FDA, CRA, etc.)Multi-framework compliance (FDA, CRA, etc.) | ||
Real-time vulnerability trackingReal-time vulnerability tracking | ||
Evidence packs for auditorsEvidence packs for auditors | ||
API/CI integrationAPI/CI integration | ||
Turnaround in days (not weeks)Turnaround in days (not weeks) |
Beat Compliance Deadlines — With Evidence You Can File
Book a 30‑minute call to discuss your product scope, regulatory targets, and certification timeline with our experts.