-
EXALTA Group
89 S Commerce Way
Bethlehem, PA
18017
United States - 700,000 square feet, 10 facilities
- (866) 761-0933
- 1600+ employees
- Founded in 2025
- Operating in Asia, Europe, Global, North America
- Visit Website
CEO
Group President & Board Member
CCO - Integrated OEM Solutions
CCO - Manufacturing Solutions
Changes saved
- Cases & Trays
- Component Parts
- Instruments
- Logistics/Supply Chain
- Manufacturing
- Materials/Metals
- Packaging
- Private Label
- Product Development
- Regulatory/Quality Assurance
- Surface Preparation/Treatments
- Testing
EXALTA is a global solutions provider for the MedTech industry, built to accelerate complex medical device programs from development through scalable manufacturing. By connecting development, regulatory, quality, and precision manufacturing within one integrated platform, EXALTA reduces handoffs, strengthens accountability, and gives leading OEMs a faster, more reliable path to bring breakthrough technologies to patients worldwide.
Integrated OEM Solutions | Manufacturing Solutions |
Turnkey, private label medical device programs, including Manufacturer of Record pathways, built to move faster from concept to launch. Development, regulatory readiness, manufacturing, and launch support are connected under one accountable partner. | Scalable contract manufacturing for complex components, implants, instruments, flexible shafts, cutting tools, assemblies, and complete systems, with integrated finishing, cleaning, passivation, packaging, and supply continuity. |
Accelerating MedTech
Integrated OEM Solutions | Manufacturing Solutions |
Turnkey, private label medical device programs, including Manufacturer of Record pathways, built to move faster from concept to launch. Development, regulatory readiness, manufacturing, and launch support are connected under one accountable partner. | Scalable contract manufacturing for complex components, implants, instruments, flexible shafts, cutting tools, assemblies, and complete systems, with integrated finishing, cleaning, passivation, packaging, and supply continuity. |
Engineering support for implants, instruments, and complete procedural systems, from early concept through design transfer. Built around manufacturability, surgeon input, cadaver lab feedback, and scalable production from the start.
Product Development
Engineering support for implants, instruments, and complete procedural systems, from early concept through design transfer. Built around manufacturability, surgeon input, cadaver lab feedback, and scalable production from the start.
Regulatory and quality expertise embedded early to support 510(k), EU MDR, technical documentation, risk management, design controls, lifecycle readiness, and post-market surveillance. A clearer path from development to launch and beyond.
Regulatory & Quality Assurance
Regulatory and quality expertise embedded early to support 510(k), EU MDR, technical documentation, risk management, design controls, lifecycle readiness, and post-market surveillance. A clearer path from development to launch and beyond.
ISO/IEC 17025:2017-accredited in-house microbiology capabilities for bioburden monitoring, endotoxin, cleaning validation, and sterilization readiness. Fewer external handoffs. Stronger regulatory preparedness. Faster movement toward launch.
Microbiology & Sterilization Readiness
ISO/IEC 17025:2017-accredited in-house microbiology capabilities for bioburden monitoring, endotoxin, cleaning validation, and sterilization readiness. Fewer external handoffs. Stronger regulatory preparedness. Faster movement toward launch.
Integrated testing support to validate performance, strengthen submissions, and prepare complex programs for launch. Connected to development, regulatory, and manufacturing teams to reduce avoidable delays.
Testing & Validation
Integrated testing support to validate performance, strengthen submissions, and prepare complex programs for launch. Connected to development, regulatory, and manufacturing teams to reduce avoidable delays.
EXALTA supports complex medical device programs across orthopedic and adjacent surgical markets.
- Spine
- Extremity
- Trauma
- Reconstruction
- Sports Medicine
- Cardiothoracic
- ENT
- Robotics
- Enabling Technology
Implants | Instruments | Cases & Trays |
| Precision-manufactured implants for spine, extremities, trauma, reconstruction, and adjacent surgical applications. Built for tight tolerances, repeatable performance, and scalable production. | Surgical instruments and instrument systems built for procedural fit, repeatable performance, and production scale. From drivers, reamers, guides, inserters, flexible shafts, and cutting tools to complete procedure-specific sets. | Custom cases and trays engineered to organize, protect, and support instrument and implant systems from production through clinical use and shipping. Built for durability, usability, and system-level readiness. |
Markets Served
EXALTA supports complex medical device programs across orthopedic and adjacent surgical markets.
- Spine
- Extremity
- Trauma
- Reconstruction
- Sports Medicine
- Cardiothoracic
- ENT
- Robotics
- Enabling Technology
Implants | Instruments | Cases & Trays |
| Precision-manufactured implants for spine, extremities, trauma, reconstruction, and adjacent surgical applications. Built for tight tolerances, repeatable performance, and scalable production. | Surgical instruments and instrument systems built for procedural fit, repeatable performance, and production scale. From drivers, reamers, guides, inserters, flexible shafts, and cutting tools to complete procedure-specific sets. | Custom cases and trays engineered to organize, protect, and support instrument and implant systems from production through clinical use and shipping. Built for durability, usability, and system-level readiness. |
130 Durham Drive
Athens, AL 35611
United States
89 S Commerce Way
Bethlehem, PA 18017
United States
12702 Trade Way Dr #3
Bonita Springs, FL 34135
United States
1 Rue Nungesser et Coli
Châtellerault 86100
France
10325 58th Place
Kenosha, WI 53144
United States
375 River Park Circle
Marquette, MI 49855
United States
2705 Corporate Flight Dr
Naples, FL 34104
United States
2821 Tingkat Perusahaan 5A
13600 Prai Penang, Penang (Pulau Pinang) 13600
Malaysia
93-95 avenue du Champ Gretz
Rang-du-Fliers 62180
France
9, Route de Marcilly
Saint-Soupplets 77165
France