ISO 13485 Certified QMS
Medtech and SaMD Software Experts


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.
Services
Wearables and BiosensorsNeed software for your CGM, biosensor, or wearable? We can help.
Explore below how wearables and biosensors are transforming digital health.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
Leverage your Data. We specialize in AI and ML for predictive analytics, pattern recognition and chatbot integration in healthcare.
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
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
Comprehensive maintenance and support designed to optimize software performance, ensure regulatory compliance, and safeguard security.
Staff Augmentation & Dedicated Teams
Show moreAccelerate project timelines and achieve your delivery goals with experienced professionals ready to integrate into your workflow.
Cybersecurity and Privacy Solutions
Implement robust security measures and cybersecurity to protect data and comply with privacy regulations (HIPAA,GDPR).
Custom Firmware Development
Development of custom firmware for biosensor and connected devices to optimize performance, add features, and ensure stable connectivity.
- Conforms with IEC 62304 (SDLC)
- Emphasizes Risk Management throughout Development Lifecycle (ISO 14971)
- Complies with Regulatory Requirements
- Ensures Traceabilty & Accountability
- Continuous Delivery/Continuous Compliance
- Test-First Methodology
- Automated Testing
- Automated Documentation
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.
Our Expertise
Sequenex has the tools, processes and resources to expedite delivery of regulated software product.
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.
- 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.
Explore Knowledge HubSeptember 25, 2025
Sequenex to Attend The Medtech Conference 2025: Driving Innovation in SaMD and Connected Health
Sequenex is heading to San Diego this October for the The Medtech Conference hosted by AdvaMed, the premier event where…September 23, 2025
Medical Device Startup Software: Customizable Platforms Accelerate FDA Pathways
Medical device startups often lose 12–18 months building custom software before they can begin trials. NEX changes that. With a…September 5, 2025
GLP-1 Ecosystem: Where’s the Clinical-Grade Software?
As GLP-1 demand soars, wellness apps are flooding the market, yet clinical-grade software remains scarce. Discover what developers need to…