Orthogonal LLC Company Profile
Qualifications: ISO 13485, FDA Registered
Markets Supplied: North America, Europe
Orthogonal develops mobile apps and cloud services for medical devices through our ISO 13485 certified QMS. We integrate Agile best practices with robust patient risk management to achieve quality at speed and optimize the value of connected health by Improving engagement and outcomes, increasing product safety, reducing regulatory risk and accelerating development and maintenance.
Our Expertise:
- iOS and Android Application Development
- Bluetooth Connectivity for Implanted and Wearable Devices
- Validated, Scalable Cloud Services
- AI Algorithms
- Integrated Cybersecurity
- Testing Automation
- FDA, EU MDR and GDPR Compliance
- User Experience and Human Factors
- Patient Engagement and Analytics
Our Experience:
- Implanted CGMS
- Insulin Pumps
- Nerve Stimulators
- Point of Care Diagnostics
- Orthopedic Devices
- Cardiac Monitoring
