REGULATORY & COMPLIANCE
Rehabwheel Inc. is committed to meeting applicable global standards for medical device safety, software integrity, risk management, and quality management. Our engineering and operational frameworks are being developed toward rigorous federal and international requirements.
QUALITY MANAGEMENT & MEDICAL STANDARDS
Rehabwheel is developing its regulatory and quality framework with consideration of applicable U.S. Food and Drug Administration requirements for medical devices, including quality-system and manufacturing requirements relevant to the eventual device classification and regulatory pathway.
Designing toward ISO 13485 principles for medical-device quality management across product development and planned San Francisco and Austin operations.
Applying a risk-management approach informed by ISO 14971 principles to identify, evaluate, control, and monitor medical-device risks throughout development.
Developing edge-AI, connected software, and embedded control-system processes with IEC 62304 medical-device software lifecycle principles in mind where applicable.
DEVELOPMENT STATUS
LegMaker remains under development. References to FDA, ISO, IEC, quality systems, risk management, or anticipated device classifications describe Rehabwheel’s regulatory planning and development framework unless expressly identified as a completed certification, registration, clearance, or approval.
COMPLIANCE INQUIRIES
For compliance audits, institutional inquiries, or regulatory documentation requests.
Rehabwheel Inc. · 655 Bryant St, San Francisco, CA 94107
