ISO 13485 Certified QMS
SaMD and Connected Devices Software Experts
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Regulatory ready and compliant by design for MedTech. Complete with “out of the box” iOS and Android apps, Patient and Clinician Dashboards and an Administrator Portal.
Services
What We MeasureSequenex rapidly develops and delivers comprehensive and compliant Software as a Medical Device (SaMD) solutions and products for the medical device and biosensor markets.
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 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 software using BLE, NFC, and WiFi tech for seamless connectivity, data exchange, and remote monitoring.
Maintenance and Support Services
Comprehensive, proactive maintenance and support designed to optimize software performance, ensure regulatory compliance, and safeguard security.
Staff Augmentation & Dedicated Teams
Accelerate 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
We specialize in expediting the delivery of SaMD, adhering to ISO 13485 and IEC 62304 standards. Our expertise spans testing, FDA compliance, and rigorous risk management, ensuring high-quality, safe solutions for healthcare.
SaMD Compliance and Development Processes
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
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
Proactively manages risks 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
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.
- 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 Hub
April 28, 2025
How to Build Post-Market Surveillance into Device Software from Day One
Post-market surveillance is required for medical device deployment. But waiting to implement it late in development increases safety and regulatory…
April 24, 2025
Why EHR Interoperability is Critical for Connected Medical Device Success
Building connected devices that integrate seamlessly with EHR systems is vital for success, but it also comes with challenges. Find…
April 16, 2025
The Importance of Domain Expertise in MedTech Software Development
Developing software for medical devices requires specialized industry knowledge and regulatory expertise not all software developers possess. This article explores…
