The global CDMO partner unifying design, manufacturing, and regulatory expertise to bring medical devices from concept to commercialization.
Our design engineering team works alongside your R&D from day one. DFM analysis, material selection, tolerance optimization, and prototyping that compresses your timeline without compromising precision.
CNC machining, injection molding, additive manufacturing, and clean room assembly across 12 global sites. 99.97% production yield with full lot traceability from raw material to finished device.
510(k), PMA, CE marking, MDR compliance — our regulatory affairs team has guided 400+ submissions across FDA, EU, and global markets. We build the quality system into every step, not as an afterthought.
CNC-machined titanium and cobalt-chrome implants with surface texturing for osseointegration. Sub-micron tolerances on articular surfaces.
Learn moreMicro-extrusion, laser cutting, and electro-polishing for cardiac and peripheral vascular devices. Clean room assembly with 100% inspection.
Learn morePrecision-machined surgical handpieces, blades, and drill assemblies. Ergonomic design validation with torque and vibration testing protocols.
Learn moreTitanium dental implants with proprietary surface treatments. Custom abutments via CAD/CAM with same-day digital workflow integration.
Learn more3D-printed PEEK and titanium spinal cages with trabecular structures. Patient-specific sizing from CT data with 48-hour turnaround.
Learn moreOn-body infusion pumps and auto-injectors with micro-fluidic precision. Combination device expertise spanning drug and device regulatory pathways.
Learn moreClinically validated manufacturing excellence
EXALTA was born from the merger of three industry leaders, each with decades of MedTech manufacturing heritage. Together, we've created a singular CDMO platform: unified quality systems, global scale, and the deep domain expertise that only comes from building hundreds of thousands of devices that are already inside patients.
Our StoryISO Class 7 & 8 environments across all major facilities
Real-time production monitoring across every line
Manufacturing centers in North America, Europe, and Asia-Pacific with unified quality systems and supply chain redundancy.
Regulatory submissions
Whether you're scaling a proven device or bringing a new concept to life, EXALTA is the manufacturing partner that makes precision inevitable.
Request a Quote