Quiet Vector provides outside technical assessment and evidence remediation across design assurance, software and system V&V, risk management, and cybersecurity.
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About
The work is usually a question that has to be answered correctly, in writing, by someone with no stake in the answer — before a submission, an inspection, an investment decision, or a launch.
35+ years in medical device systems and software-intensive, active medical devices. Active implantables, defibrillators, neurostimulators, implantable drug pumps, programmers, monitoring and patient data systems, SaMD, and combination products. Work spans R&D, Quality, and Regulatory.
Fixed-fee assessments, short remediation sprints, fractional advisory support, subcontract consulting. Remote or onsite. Based in Minnesota.
Recommended starting points: Technical Due Diligence · Independent DHF / Design Assurance Review · Software/System V&V Rescue · Cybersecurity Gap Assessment.
A short intake call clarifies scope. I tell you honestly whether I can help — and if I cannot, I say so.
— Wayne Larson, Principal Engineer, Quiet Vector LLC
Services
Deliver decision-grade technical risk findings and remediation priorities for deals and diligence. See the Technical Due Diligence page.
Outside assessment of design history file quality, traceability, and regulatory defensibility before submissions and inspections. See the Design Assurance page.
Traceability review, evidence-strength scoring, gap analysis, and prioritized action plan for troubled programs under regulatory pressure.
Repair weak linkage across threat analysis, risk controls, verification evidence, and risk files so the package is technically coherent and regulator-ready.
Full-scope review of architecture, threat handling, security risk management, verification evidence, and regulatory alignment. See the Cybersecurity page.
Assess evidence quality, traceability depth, and submission readiness against current FDA cybersecurity expectations and SW96-aligned documentation needs.
Part-time principal-level engineering depth to guide technical decisions, unblock cross-functional teams, and keep high-risk programs moving with discipline.
Some engagements are not a service. They are a single question that has stalled a program: whether a design decision holds, whether an argument will survive review, why a failure occurred, or whether the evidence supports the claim being made. That work is taken on directly.
If two or more apply, a short assessment is the usual starting point.
For PE/VC diligence teams, investor-side technical assessment, or pre-acquisition engineering evaluation, the Technical Due Diligence page provides the full scope of that engagement.
Credibility
design assurance, software and system V&V, risk management, and cybersecurity for Class II and Class III medical device programs.
contributed to the AAMI committee work that preceded IEC 62304 and to the ISPE GAMP methods development. Charter member, ASQ Software Quality Division (1991). CSQE.
Leading MedTech OEMs and global quality organizations — specific references available confidentially upon request.
Concise details help prioritize response and scope.
