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ISO 13485 Certified: IEC 62304 Compliant

Medical Device Software & SaMD Development — Built Faster

Sequenex builds medical device software and SaMD that ships months sooner — engineered under IEC 62304 within an ISO 13485–certified QMS, with DHF-ready documentation from day one. Specialists in CGM, biosensors, wearables, and connected medical devices.
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Need to Get Your Device Software Up and Running Quickly?

NEX Platform — A Prebuilt Software Foundation for Medical Devices and SaMD

The NEX Platform cuts months off SaMD and connected device development. It’s a prebuilt, customizable software foundation — iOS and Android apps, patient and clinician dashboards, an administrator portal, and secure cloud infrastructure for medical data — engineered to function as a unified system, with the IEC 62304 and ISO 13485 groundwork already in place

Reduce product development time, complexity and costs with a prebuilt and customizable software foundation for regulated medical devices and SaMD.

Built to function as a unified system, NEX includes iOS & Android apps, Patient & Clinician Dashboards, an Administrator Portal, and Secure Cloud Infrastructure for medical data.

  • Our Services

    Sequenex is a full-service software engineering and product development firm for connected medical devices, biosensors, CGM and SaMD.  

    Biosensor Integrations
    QA and Testing

    Medical Device Software Testing, QA and V&V

    Medical device software verification and validation done right the first time — automated and manual testing across mobile, cloud, and connected devices, with full traceability to requirements that holds up under audit.

    AI and ML Solutions

    AI and ML for Medical Device Software

    AI and ML for medical device software, built for the regulated path — predictive analytics and algorithm development designed for traceability, validation, and FDA-aligned documentation from the first commit.Predictive analytics and algorithm development for medical and connected device software, designed to support traceability, validation, and regulatory alignment.

  • Custom Software Development

    Software Product Development

    Connected medical device software development — mobile, cloud, and real-time data — built end-to-end under IEC 62304 within our ISO 13485–certified QMS, so your DHF and submission package come together as you build, not after.End-to-end development of connected medical device software — mobile, cloud, and real-time data — built under IEC 62304 within our ISO 13485–certified QMS.

    BLE, NFC, WiFi

    BLE, NFC, and WiFi for Connected Medical Devices

    BLE, NFC, and WiFi connectivity for medical devices — pairing, data streaming, and protocol handling that just work, integrated cleanly into your iOS and Android apps and your cloud backend.End-to-end implementation of device-to-app communication, including pairing, data streaming, and protocol handling for connected medical devices.

    Maintenance and Support Services

    MedTech Resourcing

    MedTech software engineers and dedicated teams, ready to plug in. From a single engineer filling a skills gap to a fully managed team for SaMD or connected device development — already up to speed on regulated software.Flexible resourcing for your medtech software projects, from individual engineers to dedicated teams — supporting SaMD and connected device development.

  • Staff Augmentation and Dedicated Teams

    AI-Assisted Engineering

    AI-assisted medical device software development that ships faster without losing the audit trail — engineer-controlled use of AI for development, documentation, and testing, inside an ISO 13485 QMS.

    Security and Privacy Solutions

    Medical Device Cybersecurity & Data Protection

    Medical device cybersecurity built in from architecture, not bolted on at submission — encryption, RBAC, and audit trails across device, mobile, and cloud, aligned to FDA premarket cybersecurity guidance, HIPAA, and GDPR.End-to-end security across device, mobile, and cloud, including encryption, RBAC, and audit trails, supporting HIPAA and GDPR-requirements.

    Custom Firmware Development

    Custom Firmware for Medical Devices

    Custom firmware for biosensors and connected medical devices that holds up in the real world — optimized performance, the features your roadmap actually needs, and connectivity that doesn’t drop in the field.

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Sequenex’s software development process is IEC 62304-compliant from the first sprint, with ISO 14971 risk management running in parallel — so when audit day comes, the documentation is already there.

  • IEC 62304 software lifecycle, fully documented
  • ISO 14971 risk management at every stage
  • Regulatory requirements traced to source
  • Full traceability and accountability across the SDLC

 

 

A Design History File (DHF) is the regulatory record of a medical device’s design and development, required by FDA 21 CFR 820.30 and ISO 13485. Most teams scramble to assemble theirs at submission. Sequenex delivers the complete software documentation package — software development plans, requirements, design specs, V&V records, and risk management files — already structured for direct inclusion in your DHF, aligned to design controls. So submission week is paperwork, not a fire drill.

ISO 13485 Certified QMS

Our ISO 13485 Certified QMS underscores our commitment to excellence in medtech software engineering, ensuring your projects are delivered with unparalleled precision and regulatory compliance.

View ISO 13485 Certificate

  • Our Expertise

    Sequenex develops software products for connected medical devices, biosensors, and SaMD—covering architecture, integration, testing, and risk management.

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  • SaMD Compliance and Development Processes

    SaMD development under ISO 13485 and IEC 62304 is what we do every day — not a sideline. Every project is built inside our certified QMS, with safety, efficacy, and regulatory alignment baked into the workflow rather than reviewed at the end.Specializing in SaMD, compliant medical device software development, adhering to ISO 13485 and IEC 62304 standards for safety, efficacy, and regulatory compliance.

    Testing and Quality Assurance 

    Medical device software testing that holds up under audit — unit, integration, and acceptance testing across system and subsystem level, run through automated pipelines with traceable test case management mapped to your requirements.Expert in rigorous system and subsystem testing — including unit, integration, and acceptance testing. Emphasizes automated testing, comprehensive test case management, and regulatory standards for quality solutions.

    Companion Apps Development

    Companion apps for connected medical devices — remote patient monitoring (RPM), medication adherence, chronic disease management, wearables, and data analytics — built as iOS and Android applications integrated with biosensors, CGM systems, and clinician dashboards.Remote Patient Monitoring, Patient Monitoring, Fitness & Wellness, Medication Adherence, Chronic Disease Management, Wearables, Data Analytics & Reporting

  • Risk Management

    Medical device software risk management under ISO 14971, applied from concept through post-market surveillance — hazard analysis, risk assessment, and mitigation that protects patients and clears regulatory review the first time.

    Diabetes and Biosensor Subject Matter Experts

    Diabetes and biosensor software is in our DNA — CGM, insulin pump, and connected pen integration is what we’ve shipped repeatedly. You get robust, integration-ready software from a team that already knows where the sharp edges are.We specialize in software development for diabetes and biosensor devices with a focus on robust, integration-ready, scalable solutions. CGM, pump and pen expertise.

    Quality & Regulatory

    Quality and regulatory aren’t a final-stage review at Sequenex — they’re built into every step of the medical device software development process, so the path from concept to commercial release stays on schedule.We integrate quality and regulatory best practices into every step of the software development process — ensuring your transition from concept to commercial release is seamless.

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  • Test-driven development
  • Automates testing procedures
  • Simulates device behavior
  • Ensures reliability and performance

 

  • Mobile App Persistence Library: Ensures data integrity
  • Graphing Library: Visualizes medical data
  • Logging Library (HIPAA compliant): Secure logging

  • OIDC/OAuth2 Authentication: Robust authentication mechanisms
  • Safeguards sensitive patient information
  • Automated Documentation: Automates and generates comprehensive regulatory documentation

Tools and Solutions

We use advanced solutions, tools and processes to expedite medtech and digital health software delivery. We ensure rapid development and strict regulatory compliance for faster market readiness.

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Sequenex builds medical device software, Software as a Medical Device (SaMD), and connected device firmware that ships faster — engineered under IEC 62304 within an ISO 13485-certified QMS. Specialists in diabetes, biosensor, CGM, and digital health products.
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