ISO 13485 Certification Scope

Our QMS and ISO 13485 certification does several things:

• Ensures our approach to quality puts our customers at the center of the innovation process

• Provides the flexibility to design, develop, and manufacture medical devices and 3D printed models from concept through first-in-human studies

• Raises the bar beyond clinical access to innovative product development

• Solidifies our focus on accelerating innovation to improve vascular care