Structured QMS Products for Regulated Digital Health

Building a Quality Management System should not mean starting from a blank page.

Frelong Health provides engineered QMS product suites designed for medical device and digital health teams operating under ISO 13485, IEC 62304, ISO 14971, and IEC 82304 frameworks. These systems are structured, traceable, and deployment-ready — built to establish control from day one.

Our QMS Products are not generic document bundles.
They are integrated compliance architectures.

Each framework is organized around lifecycle discipline, risk alignment, verification structure, and configuration control. Requirements connect to risk. Risk connects to controls. Controls connect to validation. Every document has a defined role within the system.

This eliminates chaos.

Instead of retrofitting compliance after development, teams begin with a structured foundation that supports scalability, audit readiness, and regulatory defensibility.

Whether launching a new SaMD product, maturing an existing QMS, or preparing for certification, our product suites provide:

• Structured document architecture
• End-to-end traceability frameworks
• Risk-based verification planning
• Audit-ready governance structure
• Scalable lifecycle integration

This is compliance built with intent. Integrated. Traceable. Controlled. Submission-ready.

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Make it compliant.

  • Stack of books on design, research, and storytelling topics, including titles like 'Think Like a UX Researcher,' 'The Design of Everyday Things,' and 'UX Storytelling.'

    Deploy it.

    Our QMS Products are structured, ready-to-deploy compliance frameworks built specifically for regulated digital health environments.

    From ISO 13485 Quality Systems to IEC 62304 software lifecycle templates, our document architectures are designed to give you immediate structure — without starting from scratch. Each framework integrates risk management, traceability, verification strategy, and configuration control into a unified system.

    These are not generic templates.
    They are engineered compliance foundations.

  • Close-up of a person's hand using a white mouse on a desk, with an Apple iMac computer displaying a document and multiple folders on the screen.

    Control it.

    Every product is built around traceability and lifecycle discipline.

    Our structured frameworks support:

    • End-to-end traceability matrices
    • Risk-based verification planning
    • Configuration and change governance
    • Submission-ready documentation architecture

    You gain clarity. Control. Confidence.

  • Four individuals sitting at a table in front of a blank white wall, viewed from behind. Two women on the left and two men on the right, two with laptops open in front of them.

    Defend It.

    A QMS is only valuable if it stands up to scrutiny.

    Our QMS Products are structured to be audit-ready, aligning with FDA expectations, ISO certification requirements, and global regulatory frameworks. Whether preparing for inspection, strengthening internal discipline, or building a scalable foundation for growth, these systems are designed to be defensible.

    Structured. Reviewable. Inspection-ready.

    Make It Happen