Resources: services

Regulated Software Quality & V&V Engineering | Netspective

Netspective's Regulated Software Quality & V&V Engineering service: safety classification, requirements-to-test traceability, and V&V plan development for IEC 62304 and related regulated-software programs.

Technology Services — Full-Stack Engineering for Regulated Systems

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

Regulatory Consulting Services — FDA, HIPAA, NIST, and QMS Programs

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.

AI Workforce Services — Compliance-Aware Automation for Regulated Operations

AI agent development, process automation, and knowledge-management systems for regulated operations, with compliance requirements (HIPAA, FDA, FedRAMP) designed in from the start.

Human Factors Engineering — FDA Usability Validation for Medical Devices

Human factors engineering for FDA medical-device submissions: use-related risk analysis, formative and summative usability testing, and the eight-section FDA HF submission package.

Penetration Testing — Evidence-Grade Security Assessment

Penetration testing across eight service types (web, mobile, network, cloud, API, red team) mapped to SOC 2, ISO 27001, CMMC, HIPAA, and OWASP, with signed, retestable evidence artifacts.

Clinical Evidence & AI Data Services — Regulatory-Grade Data Engineering

Regulatory-grade clinical data services: 21 CFR Part 11 compliance, HIPAA-safe de-identification, automated cleansing pipelines, and clinical evidence compilation for 510(k), PMA, and algorithmic submissions.