Contract engineering for consequential software

The commercial service lines that support Netspective’s engagements: regulated quality & V&V, technology services, regulatory consulting, AI Workforce services, clinical evidence & AI data services, human factors engineering, and penetration testing. Each service below connects to the same standards, templates, and diagnostics used within the engagement itself—not merely a summary of them.

Service lines

Regulated Software Quality & V&V Engineering

V&V plans, protocols, and executed evidence — the difference between "we tested it" and a package a reviewer can actually follow from requirement to result.

IEC 62304
  • IEC 62304 classification & gap review
  • Requirements-to-test traceability matrix
  • Verification protocols & automated test harness

Technology Services

Full-stack engineering — web, mobile, cloud, and data — for regulated systems, including HL7 FHIR clinical-system integration and compliance-aware delivery.

HL7 FHIR
  • Web & application development
  • Cloud architecture & DevOps
  • Integration services (HL7 FHIR, EHR/EMR)

Regulatory Consulting Services

FDA 510(k)/PMA/De Novo strategy, HIPAA compliance programs, quality management system design, NIST/FedRAMP authorization support, and ISO 14971 risk management.

FDA 510(k)
  • FDA regulatory pathways
  • QMS design (QMSR / ISO 13485)
  • NIST & FedRAMP authorization

AI Workforce™ Solutions

Agent development, process automation, and document intelligence for regulated operations, with HIPAA, FDA, and FedRAMP compliance requirements designed in from the start.

HIPAA / FEDRAMP
  • Regulated domain agents
  • Intelligent document processing
  • Human-in-the-loop decision gates

Clinical Evidence & AI Data Services

Data cataloging, governance, 21 CFR Part 11 cleansing, and clinical evidence compilation for FDA premarket submissions and algorithmic validation.

21 CFR PART 11
  • Data discovery & cataloging
  • Regulatory governance & compliance
  • Submission evidence dossiers

Human Factors Engineering

Use-related risk analysis, formative and summative usability testing, and the eight-section FDA human-factors submission package.

IEC 62366
  • Use-related risk analysis (URRA)
  • Formative usability testing
  • 8-section FDA submission package

Penetration Testing

Eight test types — web, mobile, network, cloud, API, and red team — mapped to SOC 2, ISO 27001, CMMC, HIPAA, and OWASP, with signed, retestable evidence artifacts.

OWASP
  • Web application testing (OWASP)
  • Cloud infrastructure review
  • Red team adversary simulation

Operational Truth™

Continuous, queryable, machine-verifiable proof of actual system state — replacing subjective, point-in-time compliance attestations with tamper-evident evidence.

  • Continuous Verification vs. Promises
  • Tamper-Evident Hash Chains
  • Sovereign Append-Only Records
ENGINEERING DOCTRINE NIST SP 800-137

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Start with the service line closest to your problem, or talk to an engineer about where your project actually sits across these seven.

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