Software Development for Regulated Digital Health

Building software in healthcare is different.

It is not just about shipping features. It is about engineering systems that are traceable, controlled, validated, and defensible under regulatory scrutiny.

Frelong Health provides structured software development consulting for medical device and digital health teams operating under IEC 62304, ISO 14971, ISO 13485, and related global standards. We help organizations design and execute development processes that integrate compliance directly into engineering — not as an afterthought.

Our approach aligns lifecycle planning, risk management, architecture design, verification strategy, and change control into a unified framework. Every requirement connects to risk. Every risk connects to controls. Every control connects to verification. Every release is documented, reviewable, and audit-ready.

This is disciplined acceleration.

We help teams move faster by building the structure that prevents rework, remediation, and regulatory instability later.

Whether supporting early-stage SaMD development, strengthening an existing lifecycle process, or remediating gaps before submission, our focus remains constant:

Build intelligently. Validate rigorously. Maintain continuous traceability.

Learn More

Make it stand out.

  • Two people standing in front of a glass wall with yellow sticky notes organized into columns labeled Q2, Q3, and Q4. The sticky notes contain tasks related to project planning.

    Plan it.

    Compliant software starts with the right foundation. We align your project with ISO 13485, ISO 14971, and IEC 62304 to ensure that requirements, risk management, and documentation are built into the process from day one. Whether you’re developing SaMD, SiMD, or AI/ML solutions, we help you plan for compliance from the very beginning.

    Make It
  • Computer workstation with dual monitors displaying code, a smartphone showing a Netflix playlist, a keyboard, a mouse, a coffee cup, and a camera lens in a dimly lit room with orange LED backlight.

    Build it.

    Our team supports every stage of the software lifecycle — from design and development to verification and validation. With an audit-ready Quality Management System (QMS) available to contract clients, we provide the structure and documentation you need to satisfy regulators and move forward with confidence.

    Make It
  • Computer screen displaying Google PageSpeed Insights with a score of 99 in a green circle. The page shows website performance metrics, with color-coded indicators and percentages for various web performance parameters.

    Prove it.

    Compliance isn’t complete until your software can stand up to review. We prepare the Design History File (DHF), traceability matrices, and supporting documentation that ensure your project is ready for FDA, notified body, or internal audits. The result: software that is not only innovative but also defensible, reliable, and regulatory-ready.

    Make It