MedTech Cybersecurity • Principal Engineer
Delivery of Complete Cybersecurity Documentation and assistance for your 510(k)/PMA submissions — SBOM, threat model, security risk management, architecture description, and SW96:2023 conformance — in as little as 3 weeks from kickoff, on a fixed-fee engagement.
Cybersecurity readiness
I deliver complete 510(k) cybersecurity documentation and close the gaps that block review. Hands‑on engineering, not checklists.
Wayne Larson delivers regulator‑ready cybersecurity, V&V rescue, and design‑assurance support for Class II and Class III devices.
Engineering‑level work for OEMs, quality/regulatory leaders, and investor diligence teams.
Broader consulting practice
The main site covers the full practice — engagements, proof points, and contact options. This page stays focused on cybersecurity support.
Core services
Designed for MedTech teams that need immediate, senior-level engineering clarity without extended onboarding. Each engagement is scoped to deliver regulator-ready outcomes with crisp documentation and a direct decision path.
Pricing note
Final pricing depends on device complexity, evidence quality, and execution risk. If a program carries higher regulatory exposure or a compressed timeline, a risk-adjusted premium may apply.
Fixed-fee • Fast turnaround
Complete set: SBOM (SPDX/CycloneDX), threat model (AAMI TIR57), security risk management report, architecture description, SW96:2023 conformance statement. Rapid sprint execution. 50% upfront, 50% on delivery. Gap assessment informs fixed-price quotes.
Fixed-fee • Fast turnaround
Comprehensive review of existing cybersecurity artifacts against FDA’s new demands for investigational and 510(k)/PMA new products and applicable aspects of SW96:2023. Output: prioritized gap list with remediation effort estimates. 100% upfront.
Fixed-fee • Fast turnaround
Intervention sprint on weak, fragmented, or regulator-unready software V&V evidence. Output: traceability repair plan and evidence-strength assessment. 50% upfront, 50% on delivery.
Track record
Compact proof points from high‑risk programs—delivered with regulator‑ready rigor and calm execution.
Evidence‑based
Each metric reflects stabilization, compliance, or delivery impact in real MedTech environments.
Across Class II and Class III active implantable devices
On every submission Wayne supported
For supported submissions
Client experience
Representative organizations and program environments where Wayne has delivered senior engineering leadership, cybersecurity readiness, and high-stakes V&V outcomes.
Adaptive to Your Needs & Criteria
No fabricated logos—only discreet, enterprise-friendly credit.
Why clients hire me
I focus on engineering-grade outputs that withstand FDA review, stabilize high-risk programs, and keep leadership out of prolonged remediation cycles.
Accelerate cybersecurity documentation and evidence without sacrificing traceability or rigor.
Every artifact is technically defensible and rooted in real system behavior, not boilerplate.
Evidence packages are structured for clarity, auditability, and regulator-ready responses.
Depth in active implantables translates into clear, efficient guidance for lower classes.
Accessible, responsive, and on-site when needed to unblock teams fast.
Standards & domain depth
Structured scope across device classes, globally accepted standards, and the disciplines that stabilize high‑risk programs. Presented to align with quality, regulatory, and engineering review expectations.
Scope is tailored to technical diligence, remediation planning, and independent principal‑level reviews.
Cybersecurity services PDF
A concise overview of independent cybersecurity consulting services for medical devices, including core deliverables, evidence expectations, and package options tailored for OEMs and program leaders.
Includes service overview, package options, and engagement details.
PDF OVERVIEW
Clear scope, deliverables, and engagement pathways for cybersecurity readiness and remediation.
Suitable for internal review, stakeholder alignment, and scoping discussions.
Reach Out for Quick Answers
I answer. We talk. If it makes sense, we move forward. If not, I will tell you.
Fixed-fee assessments. Short remediation sprints. Remote or onsite. Minnesota-based.
Direct Contact
Phone
612-860-8507Responsive, direct, and regulator-ready support when programs are at risk.
Footnote: dependent on complexity and execution risks.