Contract Engineering for Consequential Software
Contract Engineering Firm Since 1997Code is becoming abundant. Accountable engineering is not. Netspective is a contract engineering firm for complex and regulated software — medical devices, healthcare SaaS, GovCon, and life sciences — where software failure has clinical, regulatory, or mission consequences. We deliver architecture decisions (ADRs), verification and validation (V&V), traceability matrices (RTM), and regulatory evidence under contract, with named engineers accountable for the outcome.
We can deliver your software because we ship and operate our own.
We build and run regulated software of our own, so the delivery practices we recommend are ones we already work under. We have carried systems through FDA 510(k) submissions, FedRAMP authorizations, and HIPAA Security Rule audits ourselves.
Your engagement is led by named engineers who operate production systems every day.
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Our Software, Your Proof
We build, ship, and operate our own software platforms, including Opsfolio (governance), Medigy (healthcare), and surveilr (audit evidence).
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Submissions That Cleared
Software and evidence engineered for client 510(k) submissions that FDA cleared and for systems that achieved FedRAMP authorization, and our own platforms run under SOC 2 Type 1 and Type 2 examinations.
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Accountable Operators, Not Advisors
Engineers accountable under contract for Architecture Decision Records (ADRs), V&V evidence, and audit-grade traceability.
Get your healthcare data ready for decisions and AI. You keep control.
Ingestion pipelines for HL7 v2, FHIR R4, C-CDA and CSV, engineered inside your own AWS account or Azure subscription. Every record is validated on arrival, rejects are logged with their root cause, and failed feeds are replayed through the same checks, while you hold the encryption keys, the access policies and the code.
- Your KMS keys, your custody: built in your own AWS or Azure tenant
- PHI stays in your tenant: Netspective processes it only there, for the contracted purpose
- Validation on arrival: failed feeds replayed through the same checks
Architectural case studies & evidence
Engineering dossiers on multi-format health data intake, physician productivity and compensation data, and healthcare data strategy and reference architecture. Each one states its evidence boundary, and every engagement keeps an exit package current from the first sprint.
Explore case studies →- 1997
- Operating Since
- 29
- Years Regulated Experience
- 100+
- Projects Shipped
- SOC 2
- Type 1 & 2 Examined Controls
Consequential Engineering: Two Practices, One Standard of Proof
Code generation has become cheap. Systems that stand up before a clinician, an auditor, or a regulator have not. We organize our work into two accountable engineering practices.
Consequential Data Engineering
The problem. Critical decisions, reporting and AI workflows fail silently when the pipelines under them lack verifiable provenance, schema enforcement and auditability.
What we build. Validated, traceable data pipelines and client-owned data lake infrastructure, where every transformation can be traced back to its source.
- Healthcare Data Lake
- Clinical Evidence Data Services
- Deterministic AI & Agent Workforce
- Operational Truth™
Consequential GRC Engineering
The problem. Requirements stay trapped in static policies and spreadsheets; evidence is assembled by hand before audits and goes stale the day it is filed.
What we build. Working controls, scripted evidence collection, reproducible verification traces and audit records a reviewer can re-run.
- Opsfolio CaaS
- Opsfolio
- Qualityfolio
- Fleetfolio
- surveilr (Digital Evidence Mesh & RSSD) Queryable, sovereign SQLite evidence store
- Regulated Quality Systems (QMSR)
Methodology detailed in our forthcoming book, Consequential GRC Engineering.
Domains of Regulated Practice
Healthcare & MedTech
Medical device software and healthcare SaaS under IEC 62304, ISO 14971, HIPAA, and HL7 FHIR.
- IEC 62304 lifecycle & SaMD
- HIPAA technical safeguards
- HL7 FHIR & EHR integration
Government & Federal
FedRAMP, NIST SP 800-53, and CMMC evidence for federal and government-contracted systems.
- FedRAMP authorization evidence
- NIST SP 800-53 controls
- CMMC practice traceability
Life Sciences & Pharma
GxP-regulated systems: electronic records, computer system validation, and data integrity.
- 21 CFR Part 11 records
- GxP validation (CSV/CSA)
- ALCOA+ data integrity
Resource Hub: Architecture, Standards & Reusable Artifacts
Direct access to our foundational engineering paradigms, governance lifecycles, and open regulatory diagnostics.
Computing Paradigms
A rigorous model classifying software behavior across deterministic, probabilistic, and hybrid safety boundaries.
Unified Process (NUP)
The 7-phase enterprise lifecycle mapping regulatory gates, DHF artifact compilation, and production verification.
Why Netspective
When code is cheap to generate, the hard part is everything around it. Eight properties we are engaged to deliver:
- Compliance
- Built into every sprint, not back-filled before audit.
- Reliability
- Deterministic runtimes, bounded latency, and failure containment.
- Security
- Threat-modeled attack vectors and signed retest proof.
- Auditability
- Append-only records with provable chain of custody.
- Traceability
- Regenerable links from clinical need to test execution.
- Maintainability
- Code and documentation a successor team can own.
- Scalability
- Architecture sized for growth in load and in scope.
- Accountability
- A named engineer owns the outcome, not just the deliverable.
Ready to Build with Architectural Accountability?
Discuss your system architecture, regulatory roadmap, or engineering delivery with our technical leadership.