Manufacturing Solutions
Precision contract manufacturing at global scale. Implants, instruments, cutting tools, handles, cases, and trays produced across 10 facilities with vertically integrated post-processing.
Learn MoreOur Operating Model
Concept to Commercialization
One partner from the whiteboard stage through regulatory strategy, manufacturing, and launch.
Two Business Units. One Mission.
How We Work With You
Two distinct business units, one integrated platform.
Integrated OEM Solutions
End-to-end development, regulatory clearance, and commercial launch services. Design, develop, manufacture, and maintain medical devices under a single engagement with full lifecycle support.
Learn MoreThe EXALTA Way
Nothing Outsourced
EXALTA operates the complete medical device value chain in-house. Design. Develop. Manufacture. Maintain. Every stage is under one roof, one quality system, and one engagement.
01
Single Point of Accountability
Our partners do not manage multiple organizations across the product lifecycle. From initial concept through regulatory clearance, scalable manufacturing, and post-market maintenance, EXALTA is the single point of accountability. We hold 150+ FDA clearances and support global registrations because we own the regulatory path, not the manufacturing step alone.
02
From Concept to Production-Ready
EXALTA's design capability spans three engagement levels. Quick customization applies modifications to existing catalog devices. Bespoke design assigns a dedicated R&D engineer for instruments built from scratch, with Design for Manufacturing optimization at every stage. Our full OEM package delivers the complete path: concept, prototyping, design history file, verification and validation, regulatory registration, and market introduction support.
03
Prototyping at Production Quality
Our prototyping cells operate across global facilities, delivering production-quality instruments and implants on accelerated timelines with integrated verification, validation, and regulatory documentation.
How It Works
Six Stages. One Operating Model.
Every stage is staffed with dedicated resources — not shared capacity borrowed from other programs.
Co-Create
Whiteboard to concept
Clinical inputs, VOC, feasibility
Design
Engineering and platforms
Technology bricks, platforms, IP
Regulate
Clearance strategy
510(k), CE-MDR, technical files
Build
DFM and production
Process dev, tooling, validation
Launch
Market entry
Commercialization, market access
Scale
Growth and supply
Volume production, post-market
Integrated OEM
Turnkey systems
Manufacturing
Precision at scale
What Partners Get
Speed, ownership, compliance, and scale — under one engagement.
Integrated OEM Solutions
End-to-end development under a single engagement
Design, develop, manufacture, and maintain
510(k) and EU MDR pathway embedded
Single operating model across 3 continents
Full lifecycle support through post-market
Manufacturing Solutions
Precision contract manufacturing at global scale
Implants, instruments, cutting tools, cases, and trays
FDA registered, ISO 13485 across all 10 facilities
Vertically integrated post-processing
Scalable from prototype to high-volume production
Ready to Work the EXALTA Way?
Tell us about your program. We will show you how the EXALTA Way compresses your timeline.