Tietronix Medical

Leading the Way

For over 25+ years, Tietronix has been building secure, compliant, and innovative custom software to advance healthcare solutions. From mobile medical apps to precision diagnostic tools, and to the latest AI technology, our work reflects a deep understanding of complex medical device requirements and user needs. Taking concept to clinical deployment, we partner with life sciences to bring ideas to life — safely, efficiently, and designed for compliance.

Custom Software

Tietronix provides FDA compliant design controls with efficient and transparent development solutions.

Mobile Apps

Tietronix has expertise is in managing mobile projects for multiple operating systems and various devices.

AI & ML

Tietronix can develop your AI engagement including massive parallel processing capability, trainable algorithms, and creating Agents for the top LLM(s)

Compliant Medical Solutions

From Concept to Completion

Partner with us to turn complex clinical needs into FDA Compliant Medical Solutions.

Work With Us

Experience Matters

Our software experience spans over 25+ years of developing sophisticated software for both NASA and medical device companies, from prototype to formal FDA design controls.

FDA Compliance

Effective medical device software is intuitive, reliable and easy to use for the physician, clinician and patient. Tietronix is an ISO 13485 registered company and we excel at complying with FDA medical device regulations CFR 820.30 for custom medical software development. We design and develop custom software for the regulated medical industry, combining intuitive user experiences with rigorous FDA and CE compliance. As an ISO 13485-certified company, we specialize in building secure, scalable systems that connect traditional and mobile platforms to local or cloud-based infrastructure. Our transparent development process ensures traceability, usability, and performance—trusted by some of the world’s leading medical device innovators.

Software Solutions

Tietronix Medical adheres to the FDA and the European Medical Device Directive requiring software development processes meet rigorous regulatory, usability and performance requirements. Our strength is a consistent and cost-effective approach to software development. We build FDA- and CE-compliant custom software applications that bring critical medical tools to clinicians and patients—anytime, anywhere. Our cross-platform expertise ensures seamless performance across devices and platforms, while our regulatory knowledge accelerates time to market without compromising compliance. Whether you’re exploring a proof of concept, launching a diagnostic tool, or a patient companion app, we deliver software solutions that are secure, scalable, and globally deployable.

Cybersecurity

Tietronix Medical creates a risk-based framework for integrating cybersecurity into every phase of the medical device lifecycle spanning design controls, risk management, and threat modeling within the quality management system. It includes the required for devices with cyber risk, including a software bill of materials (SBOM), threat-modeling reports, labeling language, and documentation of cybersecurity controls to ensure that connected medical devices remain resilient to evolving cyber threats and continue to safeguard patient safety and data integrity.

Tietronix Medical

Take the Next Step

Tietronix Medical
A division of Tietronix Software, Inc.
[email protected]
(281) 404-7214

Tietronix is headquartered in Houston, near the NASA Johnson Space Center. We employ a diverse workforce to serve government and commercial clients. In business for more than 25+ years, we are committed to high quality, reliability, and service for our customers.

Tietronix is ISO 13485 registered and IEC 62304 compliant.