Transparency, safety & reliability for personalized surgery at scale
CustoMED is built on clinical rigor, regulatory integrity, and strong data protection giving surgeons, hospitals, and partners confidence at every step, from imaging to planning to point-of-care production.
Responsible, assistive AI
AI designed to support, never replace surgical judgment.
Fully reviewable & surgeon-controlled
Transparent planning & design steps
Continual accuracy monitoring
Proven workflow safety
Accuracy and consistency validated through real surgical workflows.
High-precision segmentation
Reliable PSI & model generation
Traceability across all case steps
Regulatory commitment
We design and operate CustoMED in alignment with global medical device standards.
FDA medical software guidelines
ISO 13485 · IEC 62304 · ISO 14971
Clinical validation with orthopedic experts
Point-of-care ready
Seamless, compliant production inside hospitals and 3D labs.
Compatible with any 3D printer,including leading industry systems
Built-in sterilization and post-processing workflows
Clear production guidance.
Data privacy and security
Your patients’ data is protected end-to-end.
HIPAA & GDPR compliant
Automatic client-side anonymization
Encrypted storage & transfer
Role-based access controls