QMS compliance posture
The quality management system is a living system. ISO 13485 certified, with IEC 62304 and ISO 14971 in the work. AI Auditor examines compliance against IEC 62304 and the QMS and maps each finding to a clause.
About
Grasp Health
The compliance intelligence layer for medical device and clinical AI teams
Mission
At Grasp Health, we build the products that sustain AI governance at the pace of clinical innovation. We empower medical device manufacturers and hospital procurement teams to transition safely from proof-of-concept to compliant launch—moving fast to drive lasting impact.
Why Grasp
A quality system that stays alive
Clinical AI Monitoring
Label-free drift detection for medical-device AI. Input drift (PSI), AUROC, physician utility, and gray-zone stability, with drafted surveillance reports, CAPA plans, and PCCP-aligned retraining documentation.
Patient health status
The Stroke Patient App records stroke-related risk factors and activities and produces a composite risk score as supportive reference. The physician retains responsibility. Investigational device. Not cleared or approved by FDA.
Proof of concept to launch
A faster path from proof of concept to product launch, helping teams sustain AI governance at the pace of clinical innovation.