Dosis, Inc.

Dosis, Inc. specializes in nephrology information system application software. Their primary focus is on tools designed to automate monitoring and management of patient data, particularly for anemia in dialysis patients. Examples include the Smart Anemia Manager (SAM) and Dosis SAM, which help track hemoglobin levels, optimize treatment plans, and integrate with electronic health records to improve clinical efficiency.

Dosis, Inc. is headquartered in the United States. Since their devices are classified as software-as-a-medical-device (SaMD), they operate under the U.S. Food and Drug Administration’s (FDA) regulatory guidelines. Their products fall under FDA’s Class II category, which applies to moderate-risk devices requiring performance-based standards or special controls.

Dosis, Inc.’s devices are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) system. The 510(k) registry tracks devices deemed substantially equivalent to existing approved products, while the UDI system ensures standardized identification for traceability and regulatory compliance.

The FDA classifies Dosis, Inc.’s nephrology software applications under Class II. This classification is based on the moderate risk associated with their use in managing patient data for anemia treatment in dialysis settings. Class II devices require compliance with special controls or performance standards to ensure safety and effectiveness without the need for pre-market approval.