ISO 13485 Certified QMS

Medtech and SaMD Software Experts

Sequenex is a full-service software development partner for the diabetes, wearables and connected devices markets.  Rapidly deploy your Proof of Concept, Clinical, MVP and Commercial Software Product initiatives.
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Sequenex Medtech Companion Apps NEX SaMD platform
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Sequenex Medtech Clinician Dashboard NEX SaMD platform

Need to Get Your Medtech Software Up and Running Quickly?

Save more than 80% in time and development costs with our prebuilt and configurable NEX Platform.

Device Agnostic and compliant by design for MedTech. Complete with “out of the box” iOS and Android companion apps, Patient and Clinician Dashboards and an Administrator Portal.

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  • Services

    Need software for your CGM, biosensor, or wearable?  We can help.
    Explore below how wearables and biosensors are transforming digital health.

    Wearables and Biosensors
    QA and Testing

    Testing, QA and V&V

    Verify performance and validate compliance with our robust QA and testing frameworks. Need mobile phone compatibility testing? We can help.

    AI and ML Solutions

    AI and ML Solutions

    Leverage your Data. We specialize in AI and ML for predictive analytics, pattern recognition and chatbot integration in healthcare.

  • Custom Software Development

    Custom Software Development

    Full-service design and development of medical device and digital health software solutions with an emphasis on traceability, regulatory compliance, and rapid delivery

    BLE, NFC, WiFi

    BLE, NFC, WiFi

    We deliver medical device and wearables software using BLE, NFC, and WiFi tech for seamless connectivity, data exchange, and remote monitoring.

    Maintenance and Support Services

    Maintenance and Support Services

    Comprehensive maintenance and support designed to optimize software performance, ensure regulatory compliance, and safeguard security.

  • Staff Augmentation and Dedicated Teams

    Staff Augmentation & Dedicated Teams

    Accelerate project timelines and achieve your delivery goals with experienced professionals ready to integrate into your workflow.

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    Security and Privacy Solutions

    Cybersecurity and Privacy Solutions

    Implement robust security measures and cybersecurity to protect data and comply with privacy regulations (HIPAA,GDPR).

    Custom Firmware Development

    Custom Firmware Development

    Development of custom firmware for biosensor and connected devices to optimize performance, add features, and ensure stable connectivity.

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  • Conforms with IEC 62304 (SDLC)
  • Emphasizes Risk Management throughout Development Lifecycle (ISO 14971)
  • Complies with Regulatory Requirements
  • Ensures Traceabilty & Accountability

Sequenex automates complete and compliant Design History Files (DHFs) ready for seamless integration into customer and partner Quality Management Systems (QMS).

The Sequenex 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.

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  • Our Expertise

    Sequenex has the tools, processes and resources to expedite delivery of regulated software product.   

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  • Regulatory-Ready Software & Documentation

    Specializing in expediting SaMD and digital health software development and regulatory documentation (DHF). We work directly with your Quality and Regulatory team to ensure your success.

    Testing and Quality Assurance 

    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

    Remote Patient Monitoring, Patient Monitoring, Fitness & Wellness, Medication Adherence, Chronic Disease Management, Wearables, Data Analytics & Reporting

  • Risk Management

    Proactive risk management per ISO 14971 guidelines, including hazard analysis, risk assessments, and mitigation strategies to enhance end-user safety and regulatory compliance.

    Diabetes and Biosensor Subject Matter Experts

    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

    Continuous Delivery and Continuous Compliance: We integrate quality and regulatory best practices into every step of the software development process starting at Day One.

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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.

Knowledge Hub

SaMD News & Industry Updates.

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SaMD and Connected Devices Software Experts
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