Sequenex

Services

End-to-end engineering for regulated software

Every discipline below runs inside the same ISO 13485-certified QMS — so the documentation your submission needs is produced as the engineering happens.

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.