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.
Tietronix adheres to the FDA and the European Medical Device Directive requiring software development processes meet rigorous regulatory, usability and performance requirements. Tietronix utilizes a proprietary Quality Management System (QMS) product suite to manage software development projects ensuring reliable, repeatable compliance with relevant standards (IEC 62304, ISO 14971 and a range of additional international standards). Our strength is a consistent and cost effective approach to software development.
Tietronix provides FDA compliant design controls with efficient and transparent development solutions. We specialize in defining clear requirements and connecting traditional and mobile platforms securely to networked local or cloud based resources. Some of the largest science and medical device companies in the world trust us with their next development project - how can we help you?
At Tietronix, we not only develop good software, we create medical software that matters!