Accelerating MedTech — Read the Press Release

Precision Engineering. Global Scale.

Integrated MedTech OEM Partner

Your global Speed-to-Market enabler — from design through market clearance to full-scale commercial launch.

The EXALTA Advantage Markets We Serve
FDA Registered ISO 13485 CDMO+ Partner

Trusted by Leading MedTech Companies

Traditional CMOs manufacture. EXALTA co-develops.

Speed. Agility. Scale. In One Partner.

We integrate design, engineering, regulatory, manufacturing, and post-market surveillance inside a single platform, so you move from idea to income without piecemealing suppliers.

01

Co-Creation, Not Contracting

Access patented, regulatory-cleared technology bricks and platforms spanning Spine, Extremities, Trauma, Recon, and Cardiothoracic. Co-develop differentiated products to rapidly fill portfolio gaps.

02

Global Scale, Local Compliance

Certified legal manufacturer with established QMS infrastructure eliminates setup delays. Leverage turnkey 510(k)- and EU MDR-cleared systems across a global manufacturing footprint with nearshoring options for supply chain resilience.

03

Speed Without Compromise

DFM optimization reduces production costs and accelerates time-to-market. Strategic inventory and flexible supply chain enable immediate component availability — consistent quality from prototype to high-volume manufacturing.

Your End-to-End Integrated Partner for Program Acceleration

DFM Optimization

Collaborative DFM, material selection, and tolerance optimization from day one.

We combine cutting-edge innovation with medical-grade engineering excellence, delivering differentiated products that capture market share while maintaining IP protection and competitive advantage.

  • Design-for-manufacturing optimization reduces costs and accelerates timelines
  • Material selection and tolerance analysis built into every engagement
  • Patented technology bricks spanning Spine, Extremities, Trauma, Recon, and Cardiothoracic

Rapid Iteration

From concept models to functional prototypes in weeks, not months.

Rapid iteration cycles compress your development timeline. Move from napkin sketch to production-ready prototype without switching partners or losing continuity.

  • Concept models through functional prototypes under one roof
  • Co-develop differentiated products to rapidly fill portfolio gaps
  • Continuous design iteration with manufacturing feedback loops

Risk Mitigation

Mechanical, biocompatibility, and fatigue testing to derisk before submission.

Validated processes deliver consistent quality from prototype through high-volume manufacturing. Comprehensive testing infrastructure derisks your device before it reaches a regulatory desk.

  • Mechanical, biocompatibility, and fatigue testing in-house
  • Validated design data and documentation templates
  • Consistent quality from prototype to high-volume manufacturing

Market Access

510(k), CE marking, and MDR compliance with 150+ FDA clearances.

Comprehensive technical file development and maintenance by regulatory experts ensures first-time approval success and accelerated market entry.

  • Leverage turnkey 510(k)- and EU MDR-cleared systems
  • Technical file development supports first-time approval success
  • Certified legal manufacturer with established QMS infrastructure

Production at Scale

CNC, injection molding, additive manufacturing, and clean room assembly at scale.

State-of-the-art production facilities with validated processes deliver consistent quality from prototype to high-volume manufacturing without scaling bottlenecks.

  • Global manufacturing footprint across 12 sites, 3 continents
  • Nearshoring options for supply chain resilience
  • 700K+ sq ft of manufacturing capacity

Full Traceability

Incoming, in-process, and final inspection with full lot traceability.

Strategic inventory management and flexible supply chain ensure immediate component availability, eliminating lead-time delays and enabling rapid market response.

  • ISO 13485 certified across all global sites
  • Incoming, in-process, and final inspection at every stage
  • Full lot traceability from raw material to finished device
150+510(k) Clearances
30+Global Registrations
55+R&D Engineers
250+Patents Issued
100+End-to-End Launches

Clinical Markets

Markets We Serve

Spine

CNC-machined titanium and cobalt-chrome spinal implants with surface texturing for osseointegration.

Robotics & Navigation

Surgical robotics platforms and computer-assisted navigation systems for next-generation precision.

Growth

Trauma

Titanium trauma implant systems with modular fixation options for acute and complex fracture cases.

Lower Extremities

Precision plating, screws, and instrumentation for lower-extremity fracture repair and reconstruction.

Upper Extremities

Shoulder, elbow, and wrist implant systems with precision-machined components and validated instrumentation.

See All Markets →

Global Presence

12 Facilities Across 3 Continents

Nearshoring, supply chain resilience, and rapid program execution.

Bethlehem, PA

Headquarters

Corporate HQ and primary manufacturing campus.

Rang-du-Fliers, France

Europe — Intech HQ

118,000 sq ft European headquarters and manufacturing.

Châtellerault, France

Europe — Center of Excellence

Spine, extremities and trauma implant manufacturing.

Penang, Malaysia

Asia-Pacific

Asia-Pacific manufacturing and supply chain operations.