Accelerating Regulated Software Delivery
Trusted Technology Partner Since 1997Of course AI can write code. But who's helping you ship your regulated product? There's a canyon between code and delivery, filled with compliance, verification, audits, security, and most importantly accountability to outcomes. While others are prompting, we're building bridges across that canyon. Bridges that carry production systems, not prototypes.
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 been through FDA submissions, federal authorizations, and HIPAA audits ourselves.
Your engagement is led by people who run production systems every day.
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Our Products, Your Proof
We build, ship, and operate our own software platforms, including Opsfolio, Medigy, and surveilr.
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Real Submissions, Real Approvals
FDA clearances, FedRAMP authorizations, and a SOC 2 Type 2 attestation.
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Operators, Not Just Advisors
Code and engineering artifacts built to withstand production operation and regulatory scrutiny.
- 1997
- Operating Since
- 27+
- Years Regulated Experience
- 100+
- Projects Shipped
- SOC 2
- Type 1 & 2 Audited Architecture
Commercial Service Lines
Contract engineering delivered with deterministic outcomes.
Regulated Software QA & V&V
V&V plans, safety classification, and executed traceability evidence for FDA premarket submissions.
- IEC 62304 classification & gap review
- Traceability matrix (RTM)
- Automated verification harness
- Test protocol execution
Technology Services
Full-stack engineering for regulated systems.
- Web & mobile applications
- Cloud architecture & DevOps
- HL7 FHIR clinical integrations
- Compliant delivery pipelines
Regulatory Consulting
FDA, HIPAA, NIST, and FedRAMP programs led by a named engineer.
- FDA 510(k)/PMA pathways
- QMS design (QMSR / ISO 13485)
- ISO 14971 risk management
- NIST & FedRAMP authorization
AI Workforce™ Solutions
Agents for regulated operations, with every action logged and reviewable.
- Regulated domain agents
- Intelligent document processing (IDP)
- Human-in-the-loop decision gates
- Model validation
Clinical Evidence Data
Data hygiene and evidence preparation for regulatory submissions.
- 21 CFR Part 11 data cleansing
- Clinical cataloging
- Interoperability pipelines
- Submission evidence dossiers
Human Factors & Usability
Usability engineering that ends in a submission-ready package.
- Use-related risk analysis (URRA)
- Formative usability testing
- Summative validation
- 8-section FDA submission package
Penetration Testing
Eight test types with signed, retestable evidence.
- OWASP web & mobile testing
- Cloud configuration audit
- API testing
- Retestable evidence artifacts
Operational Truth™
Continuous, machine-verifiable proof of system state.
- Continuous machine-verifiable state
- Tamper-evident hash chains
- Append-only audit trails
- NIST SP 800-137 alignment
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.