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MEDICAL DEVICE SOFTWARE · IEC 62304 · ISO 13485 CERTIFIED


Medical Device Software Development - Built Faster. Designed for Submission.

Medical device software development is the engineering of software intended for use with or as a regulated medical device, built under IEC 62304 within an ISO 13485-certified QMS.
Sequenex delivers this end-to-end for connected devices, biosensors, CGM, and SaMD, with submission documentation produced as the engineering happens, not assembled at submission.
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Medical Device Software Development — Built Faster, Cleared Sooner

Comprehensive Software Development for Regulated Medical Devices

Medical device software development isn't one activity; it's a coordinated lifecycle covering planning, requirements, architecture, implementation, V&V, release, and post-market support. Sequenex covers every stage under an ISO 13485-certified QMS, with regulatory artifacts generated as engineering happens.

  • 01

    Full-Lifecycle Software Engineering

    End-to-end medical device software engineering, from concept to commercial release, built to IEC 62304 across mobile, cloud, embedded, and AI/ML.
    • Concept-to-launch development across iOS, Android, web, embedded firmware, and cloud
    • Built with the right level of rigor from the start: architecture, verification, and documentation are aligned to the product’s risk profile, IEC 62304 classification, and regulatory strategy.
    • Complete requirements traceability throughout the software development lifecycle
    • Sprint-by-sprint regulatory artifacts so submission preparation isn’t a fire drill

  • 02

    Regulatory & Quality Management

    Software developed inside an ISO 13485-certified QMS, with risk management under ISO 14971 and design controls aligned to FDA 21 CFR Part 820.30.
    • Our QMS has cleared multiple ISO 13485 audits and is certified, so your engineering happens inside that proven system
    • ISO 14971 risk files updated as architecture decisions get made, not reconstructed at submission
    • Design History File artifacts generated automatically through the development process
    • Built with the right level of rigor from the start: architecture, verification, and documentation are aligned to the product’s risk profile, IEC 62304 classification, and regulatory strategy.
    • Engineering documentation structured to support global regulatory pathways, including FDA, EU MDR, Health Canada, and other international markets.

  • 03

    Connected & Cloud Architecture

    Modern medical device software is rarely standalone. Sequenex builds connected, cloud-enabled architectures designed to support future integrations with external systems and partners.
    • Native iOS and Android companion apps tested across real device matrices
    • Cloud infrastructure on AWS, Azure, or GCP is architected to support HIPAA and GDPR compliance requirements
    • Real-time data pipelines that hold up under real-world connectivity, not lab conditions
    • Data dashboards with audit logging and device-data-driven configurable views, built on a foundation that can be adapted for patient, caregiver, clinical, research, or commercial use cases.

  • 04

    AI/ML and Advanced Analytics

    AI-enabled features, machine learning integrations, and advanced analytics for connected medical devices, developed within a compliant IEC 62304 and ISO 13485 software lifecycle.
    • AI/ML algorithm development and advanced analytics, built under the rigor of our quality management system.
    • Engineering deliverables structured to feed your regulatory team’s submission, including AI/ML-specific documentation where your pathway requires it
    • Predictive analytics and reporting foundations, scoped to your product’s regulatory pathway
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WHY SEQUENEX



How Sequenex Cuts Months From Medical Device Software Timelines

The first six to nine months of most medical device software programs go into scaffolding, building the QMS, the iOS and Android companion apps, the cloud, the auth layer, the documentation framework. NEX gives you all of that prebuilt and customizable. NEX gives you the foundation that otherwise takes six to nine months to build.

Most teams treat regulatory documentation as a phase that comes after the engineering work. We treat it as an output of the engineering work: requirements, design specs, V&V records, risk files, all generated alongside code. Submission week looks like software documentation, verification evidence, traceability, and engineering deliverables are produced throughout development to support regulatory submissions by the deadline.

Diabetes, biosensors, CGM, insulin pumps, smart pens, connected devices, these aren’t aspirational verticals. They are categories in which our team has subject-matter expertise, drawn from combined years of work in regulated medical device software.

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nex platform architecture

Built for Scale, Designed for Compliance

The engineering process behind every Sequenex project is audited, documented, and certified. The standards stack below isn’t aspirational — it’s how we work, every day, on every program.

Sequenex develops software, documentation, verification evidence, cybersecurity artifacts, and engineering deliverables that support the manufacturer’s regulatory strategy and submission activities.

Compliance Standards

IEC 62304, ISO 13485, ISO 14971Regulatory Coverage: FDA 21 CFR Part 820, EU MDR
Advanced analytics
Custom branding
Engineering CoverageMobile, cloud, embedded, AI/ML
Storage integrations
AI assistant
Automated reports
Vertical DepthDiabetes, biosensors, CGM, pen and pumps, wearables

Ready to Build Medical Device Software Designed for FDA Submission?

Whether you're starting fresh or accelerating an in-flight program, the conversation that matters is what your roadmap looks like and where we can compress it. Let's have it.
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