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.