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Interfacing Integrated Management System (IMS)Interfacing’s IMS is an AI-enabled platform that combines business process modeling, quality management, controlled documentation, and governance/risk capabilities in a single hub. Organizations rely on IMS to document and automate workflows, maintain versioned records, manage risk programs, and keep compliance activities aligned with regulatory requirements through full lifecycle traceability. Developed for industries where accountability and oversight are essential, including aerospace, pharma/biotech, finance, and government, IMS delivers operational insight, workflow automation, and intelligent recommendations that help reduce risk and improve quality outcomes. The platform holds ISO 27001 certification and includes 21 CFR Part 11 validation, supporting secure use in high-compliance environments. Additional capabilities include low-code app creation, AI-based process mining, audit management, CAPA and training modules, and performance dashboards. AI improves governance accuracy, strengthens compliance posture, and supports ongoing improvement.
What is eTraceLine?
A comprehensive solution for the management of hospital transfusions, laboratory services, and reference laboratories has been introduced, offering an effective way to track and optimize blood components from donation to transfusion. This innovative system simplifies various processes, including managing patient records, ordering blood and lab tests, performing analyses, transforming products, monitoring inventory, coordinating shipping, ensuring hemovigilance, utilizing RFID storage, and providing full traceability throughout the supply chain. Its versatile design makes it an excellent fit for both small clinics and large healthcare institutions. Additionally, it supports the complete automation of blood supply chain management, which can greatly improve operational workflows. The software seamlessly integrates with hospital information systems, laboratory devices, and numerous third-party applications, enhancing overall efficiency. Discover how MAK-SYSTEM's cutting-edge software solutions can revolutionize healthcare management in your organization. By joining us, you can be part of the exciting advancements in medical technology ahead. With eTraceLine adhering to the European Medical Device Regulation (EU) 2017/746 and PHS available via the 510(k) regulatory pathway, these solutions prioritize safety and effectiveness in healthcare delivery. This integration is set to significantly improve both operational efficiency and patient outcomes, thereby benefiting the entire healthcare ecosystem.
What is Orthogonal?
Orthogonal focuses on providing specialized development services aimed at the design and growth of Software as a Medical Device (SaMD) along with interconnected medical device systems, merging advanced engineering practices with a strong commitment to regulatory compliance. Their approach encompasses the full spectrum of the product lifecycle, incorporating aspects such as user experience design, integration of human factors, requirement specification, risk assessment, Agile software development, and meticulous verification and validation procedures to ensure both safety and operational efficiency. By applying Agile methodologies specifically adapted for regulated environments, they enable iterative development, foster rapid feedback cycles, and support continuous improvements while maintaining adherence to regulatory guidelines such as the FDA, EU MDR, and ISO standards. Additionally, Orthogonal supports the creation of a variety of applications, including mobile, web, and desktop solutions, as well as cloud-based systems, artificial intelligence algorithms, and SDKs that facilitate integration with third-party platforms, allowing medical devices to connect effortlessly, analyze data effectively, and deliver critical insights. This all-encompassing strategy not only leads to innovative solutions that comply with industry benchmarks but also significantly improves patient care and enhances operational productivity, ultimately benefiting healthcare providers and patients alike.
Integrations Supported
AgentMail
Andi
Apollo
Claude Code
Crustdata
Fiber AI
Gemini
Google Calendar
Instagram
Klaus
Integrations Supported
AgentMail
Andi
Apollo
Claude Code
Crustdata
Fiber AI
Gemini
Google Calendar
Instagram
Klaus
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
MAK-SYSTEM
Company Location
North Macedonia
Company Website
mak-system.com/products/etrace-line/
Company Facts
Organization Name
Orthogonal
Date Founded
2025
Company Location
United States
Company Website
www.orthogonal.com