Orthogonal, LLC
Orthogonal is a leading medical device software developer specializing in SaMD and connected device systems. They combine Agile methods and regulatory compliance to build, evolve, and scale innovative healthcare solutions that fit into patients' daily lives. With over 15 years of experience, Orthogonal helps companies navigate FDA clearance and market entry, focusing on digital health, device development, and regulatory standards.
Industries
Nr. of Employees
small (1-50)
Orthogonal, LLC
Chicago, Illinois, United States, North America
Products
Bluetooth for Medical Devices (white paper)
A white paper covering the implementation considerations, risks and best practices for Bluetooth Low Energy in medical device systems.
Software as a Medical Device: What It Is & Why It Matters (white paper)
An overview of the SaMD category, regulatory context and considerations for development and commercialization.
AI & Medical Devices (white paper)
White paper discussing opportunities and challenges of integrating AI into medical device software.
Agile in an FDA Regulated Environment (eBook)
eBook describing adaptation of Agile practices to meet FDA and other regulatory requirements for medical software development.
Bluetooth for Medical Devices (white paper)
A white paper covering the implementation considerations, risks and best practices for Bluetooth Low Energy in medical device systems.
Software as a Medical Device: What It Is & Why It Matters (white paper)
An overview of the SaMD category, regulatory context and considerations for development and commercialization.
AI & Medical Devices (white paper)
White paper discussing opportunities and challenges of integrating AI into medical device software.
Agile in an FDA Regulated Environment (eBook)
eBook describing adaptation of Agile practices to meet FDA and other regulatory requirements for medical software development.
Services
SaMD and connected device software engineering
Full lifecycle software engineering for SaMD and companion apps, from product definition through design controls and delivery.
Quality systems engineering and eQMS implementation
Design, implementation and remediation of quality management systems and electronic QMS tailored for medical device software projects.
Verification, validation and test automation
Test strategy, automated test-suite development, and execution to support verification and validation under design controls.
Human factors and usability engineering
User research, workflow modeling, formative and summative usability testing and human factors documentation for regulatory submissions.
Bluetooth and mobile connectivity engineering
Design and implementation of BLE-based connectivity, pairing workflows, and mobile application integrations for wearable and device systems.
Cloud architecture and data platforms for medical devices
Cloud backend design for device data ingestion, secure storage, analytics and clinical integrations aligned with medical-device requirements.
SaMD and connected device software engineering
Full lifecycle software engineering for SaMD and companion apps, from product definition through design controls and delivery.
Quality systems engineering and eQMS implementation
Design, implementation and remediation of quality management systems and electronic QMS tailored for medical device software projects.
Verification, validation and test automation
Test strategy, automated test-suite development, and execution to support verification and validation under design controls.
Human factors and usability engineering
User research, workflow modeling, formative and summative usability testing and human factors documentation for regulatory submissions.
Bluetooth and mobile connectivity engineering
Design and implementation of BLE-based connectivity, pairing workflows, and mobile application integrations for wearable and device systems.
Cloud architecture and data platforms for medical devices
Cloud backend design for device data ingestion, secure storage, analytics and clinical integrations aligned with medical-device requirements.
Expertise Areas
- Software as a Medical Device (SaMD) development
- Connected device and Bluetooth Low Energy integration
- Regulatory compliance and QMS (ISO 13485, IEC 62304, ISO 14971)
- Agile and test-driven development for regulated products
Key Technologies
- Bluetooth Low Energy (BLE)
- Mobile application development
- Cloud-native architectures
- FHIR and EMR integration