Three industries where software has to do more than merely run
Netspective builds for regulated and safety-critical environments — healthcare and MedTech, government and federal, and life sciences and pharma. Each industry below links into the standards, artifacts, and diagnostics that actually govern it.
Healthcare & MedTech
Software as, or embedded in, a medical device, and healthcare SaaS that handles PHI. One discipline covers both: IEC 62304 safety classification, ISO 14971 risk management, FDA premarket documentation, HIPAA Security Rule safeguards, and HL7 FHIR integration.
What we deliver
- IEC 62304 software classification and lifecycle documentation
- ISO 14971 risk management files
- FDA 510(k)/PMA software documentation under QMSR
- HIPAA Security Rule technical safeguards
- EHR/EMR and HL7 FHIR integration
- Patient portals, telehealth, and clinical decision support
- Requirements-to-test traceability and V&V evidence
- Human factors, cybersecurity, and SBOM evidence
Go deeper: IEC 62304 practical guide · HIPAA engineering practices
Government & Federal
Federal and government-contracted systems built to NIST and FedRAMP requirements, with evidence an authorizing official can inspect: agency modernization, secure data platforms, and continuous monitoring.
What we deliver
- FedRAMP authorization evidence
- NIST SP 800-53 control implementation
- NIST SP 800-218 SSDF attestation
- CMMC practice traceability
- Federal agency modernization
- Secure data platforms
- Continuous compliance monitoring
- Identity and access management
Go deeper: FedRAMP engineering evidence · NIST SSDF · CMMC practices
Life Sciences & Pharma
GxP-regulated systems: 21 CFR Part 11 electronic records and signatures, computer system validation (CSV/CSA), and data integrity (ALCOA+) evidence for pharmaceutical, biotech, and research organizations.
What we deliver
- 21 CFR Part 11 records and signatures
- Computer system validation (CSV/CSA)
- Data integrity (ALCOA+) controls
- Research data management platforms
- Clinical trial data systems
- Regulatory submission workflows
- Laboratory information systems
- Real-world evidence platforms
Go deeper: Life sciences GxP and Part 11
Ready to Build?
Start with the industry closest to your system, or talk to an engineer about which standards actually govern it.