Mobile apps
iOS & Android companion apps with persistence, graphing, and HIPAA-ready logging libraries.
ISO 13485-certified · IEC 62304
Medical device software& SaMD development —built faster.
Sequenex builds medical device software and SaMD that reach submission months sooner — engineered under the rigor of an ISO 13485-certified QMS to IEC 62304, with DHF-ready documentation produced as engineering happens.
ISO 13485IEC 62304ISO 14971FDA 21 CFR 820.30HIPAADHF-readyOIDC / OAuth2CGM · Pumps · Pens
Prebuilt foundation
The NEX Platform
Six to nine months of engineering scaffolding, day one: iOS and Android apps, patient and clinician dashboards, admin portals, and secure cloud infrastructure. Develop deviceless with device simulators — your hardware doesn’t need to exist yet.
Dashboards
Patient and clinician dashboards plus admin portals — RBAC and audit trails included.
Secure cloud
OIDC/OAuth2 authentication and encrypted infrastructure, compliant from the start.
Simulators
Deviceless development against device simulators — start software before hardware.
What we build
Nine disciplines, one regulated pipeline
Software Product Development
Connected medical device software development — mobile, cloud, and real-time data.
Testing, QA and V&V
Medical device software verification and validation done right the first time.
AI & ML for Medical Devices
Predictive analytics and algorithm development for regulated medical environments.
Biosensor Integrations
CGM, insulin pumps, and connected pens — the sensor categories we know best.
BLE, NFC & WiFi Connectivity
Reliable wireless links between devices, apps, and secure cloud infrastructure.
Cybersecurity & Data Protection
Encryption, RBAC, and audit trails — patient data protected end to end.
Custom Firmware
Embedded software for medical devices, built and tested to IEC 62304.
AI-Assisted Engineering
Engineer-controlled use of AI for development, documentation, and testing.
MedTech Resourcing
MedTech software engineers and dedicated teams with regulated-software expertise.
ISO 13485 · IEC 62304 · ISO 14971
Compliance is the process, not a phase
IEC 62304 lifecycle
Software lifecycle documentation with full traceability across the SDLC, integrated with ISO 14971 risk management.
Continuous Compliance
Test-first methodology, automated testing, and automated documentation — delivery and compliance in one pipeline.
DHF-ready documentation
The Design History File your submission needs (FDA 21 CFR 820.30, ISO 13485) — produced as engineering happens, not reconstructed after.
ISO 13485certified QMS
IEC 62304lifecycle compliance
0 moscaffolding in NEX, day one
0%traceability across the SDLC
Where we run deepest
Expertise that holds up under audit
SaMD development
Daily SaMD work aligned to ISO 13485 and IEC 62304.
Audit-proof testing
Unit, integration, and acceptance testing with traceable test-case management mapped to requirements.
Companion apps
Remote patient monitoring, medication adherence, chronic disease management, and wearables.
Risk management
ISO 14971 applied from concept through post-market surveillance.
Diabetes & biosensors
CGM, insulin pump, and connected pen integration — our home turf.
Regulatory alignment
Engineering mapped to IEC 62304, ISO 14971, and DHF documentation requirements.
Knowledge hub
Latest from the lab
May 2026
Apple App Store Medical Device Compliance
How the new rule changes the digital-health go-to-market strategy.
Read →April 2026Building CGM Software in 2026
Market outlook, software trends, and regulatory realities for hardware companies.
Read →April 2026Wellness vs Medical Device Regulation
The line is thinner than you think.
Read →Reach submission months sooner.
Tell us about your device — we’ll tell you what NEX already covers.
Contact us