ISO 13485 Certified

The Future of MedTech is Accelerating

Integrated CDMO solutions from concept to commercialization. Three legacy companies, united as one, delivering speed to market without compromising precision.

99.97%
Production Yield
Trusted by industry leaders
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Global Facilities
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Engineers & Scientists
ISO 13485
Certified Operations
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Product Launches
What We Do

Precision in Every Detail

Our vertically integrated manufacturing process ensures absolute quality control from prototyping to mass production.

Design & Development

From concept through detailed engineering design, DFM analysis, and design verification. Our engineers partner with you to optimize every dimension.

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Prototyping

Rapid prototyping with multiple technologies -- 3D printing, CNC machining, injection molding -- to validate designs before full-scale commitment.

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Testing & Validation

Comprehensive biocompatibility, mechanical, and performance testing with in-house labs equipped for ISO 10993 and IEC 60601 standards.

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Regulatory Approval

Full regulatory strategy and submission support -- 510(k), PMA, CE marking, and international registrations handled by our expert team.

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Manufacturing

ISO 13485-certified production with cleanroom environments, advanced automation, and capacity for high-mix, high-volume operations.

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Quality Control

Zero-defect culture with real-time SPC monitoring, automated inspection, and full traceability from raw material to finished device.

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New Release

The Integrated CDMO Platform

A unified approach to medical device development that combines design, prototyping, validation, and manufacturing under one roof. Reduce handoffs, eliminate delays, and maintain complete traceability from concept to commercialization.

End-to-end project management
Real-time production analytics
Digital twin simulation
Automated compliance reporting
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CDMO Platform Dashboard
Clinical Markets

Specialized Capabilities

Deep domain expertise across the most demanding segments of the medical device industry.

Surgical

Robotics, visualization systems, and precision surgical instruments for next-generation operating rooms.

Dental

Implants, prosthetics, and digital dentistry solutions manufactured with sub-micron accuracy.

Spinal

Fusion devices, motion preservation systems, and biologics engineered for the complex demands of spinal surgery.

ISO 13485 Certified Facility
Quality Assurance

Quality Beyond Compliance

Our quality management system goes far beyond meeting minimum standards. We embed quality into every step of the manufacturing process, from incoming material inspection to final device release, ensuring every product meets the highest standards of safety and efficacy.

Zero-defect initiative in production lines
Full traceability of every component
Sustainable manufacturing practices

Ready to Accelerate Your Next Product?

Connect with our engineering team to discuss your project requirements. From feasibility through full-scale production, we are your single-source CDMO partner.

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Stay Ahead.

The MedTech landscape is evolving faster than ever. Stay first in line of innovation and impact. Let's discuss how EXALTA can accelerate your next product.

Concept-to-commercialization in a single partnership
FDA-registered, ISO 13485-certified facilities
Dedicated engineering team for your program
Global scale with 50+ specialized facilities

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Stay first in line of innovation and impact.