Regulatory & IP
Developing trusted medical software through rigorous quality and regulatory processes
Directed Systems develops clinical software for healthcare environments where safety, reliability and usability are essential.
Our products are developed using established medical device quality and software lifecycle practices, with a focus on regulatory compliance, risk management, cybersecurity and clinical usability.
DS Aware™ - FDA-cleared Software as a Medical Device
DS Aware™ is an FDA-cleared Software as a Medical Device (SaMD) intended to assist healthcare professionals in managing blood pressure, haemodynamic stability and the cardiovascular system during anaesthesia.
The FDA 510(k) clearance recognises DS Aware™ as a medical device that meets applicable requirements for safety and effectiveness within its intended use.
FDA Clearances
510(k) Number: K190955
Decision Date: 27th November 2019
510(k) Number: K212529
Decision Date: 23rd November 2021
Directed Systems develops clinical software for healthcare environments where safety, reliability and usability are essential.
Our products are developed using established medical device quality and software lifecycle practices, with a focus on regulatory compliance, risk management, cybersecurity and clinical usability.
Developing trusted medical software through rigorous quality and regulatory processes
Directed Systems develops clinical software for healthcare environments where safety, reliability and usability are essential.
Our products are developed using established medical device quality and software lifecycle practices, with a focus on regulatory compliance, risk management, cybersecurity and clinical usability.
Quality Management System
Directed Systems operates a quality management framework aligned with internationally recognised medical device standards.
Our development and quality processes include:
ISO 13485
Quality management systems for medical devicesISO 14971
Risk management for medical devicesIEC 62304
Software lifecycle processes for medical device softwareIEC 62366-1
Usability engineering for medical devicesIEC 60601-1
General requirements for basic safety and essential performance of medical electrical equipment
These frameworks support a structured approach to software development, verification and validation, risk management, usability engineering and ongoing product improvement.
Software Safety and Cybersecurity
Designed for healthcare environments
Healthcare software must be designed with safety, reliability and security in mind.
DS Aware™ incorporates controls designed to support integration within hospital environments, including:
Secure software updates
Encrypted communications
Controlled access to system functions
De-identified data handling
Secure cloud connectivity
Cybersecurity considerations are incorporated throughout the product lifecycle.
Intellectual Property
Protecting innovation in hemodynamic software
Directed Systems has developed proprietary technology supporting the acquisition, processing and interpretation of physiological data to provide meaningful hemodynamic insight.
Our intellectual property strategy supports continued innovation in clinical decision support and perioperative analytics.
Regulatory status of our products
Directed Systems develops complementary software solutions with different intended purposes.
DS Aware™
FDA-cleared Software as a Medical Device providing real-time hemodynamic decision support during anesthesia.
DS Insight™
A secure cloud-based analytics platform that processes de-identified perioperative data to support case review, quality improvement and clinical analysis. DS Insight™ is not a medical device and does not provide patient-specific clinical decision support.