Design
Voice of customer research. Design inputs and validation labs. R&D and product design with 55+ engineers. Design for manufacturability. Design testing.
One Partner. Full Product Lifecycle. Accelerating MedTech.
Exalta is a vertically integrated partner for medical device companies. From product design and regulatory clearance through scalable manufacturing and post-market support, we deliver the full value chain under one quality system. 150+ FDA clearances. 100+ end-to-end launches. Your team focuses on surgeons and patients. We bring your products to market.
Partnership Model
Your Focus. Our Infrastructure.
OEM teams carry growing demands across product development, regulatory compliance, and manufacturing scale. Exalta absorbs the full scope of these functions through two complementary business units: Manufacturing Solutions for precision contract manufacturing, and Integrated OEM Solutions for end-to-end development, clearance, and launch.
This means fewer handoffs, shorter timelines, and a single quality system from concept to commercial product. Our 55+ R&D engineers and global manufacturing network support programs across spine, trauma, extremities, cardiothoracic, and sports medicine.
- Product design and development
- Regulatory and clinical strategy
- Manufacturing and supply chain
- Post-market lifecycle management
In-House Capabilities Across Four Phases
Develop
Supply chain management. Design transfer from R&D. Regulatory and clinical strategies with 150+ FDA clearances to date. Global market authorizations across 30+ markets. Innovation commercialization.
Manufacture
Global manufacturing network. Class 7 clean room operations. In-house microbiology lab. Logistics and fulfillment. Risk management and post-market surveillance.
Maintain
Post-market clinical follow-up. Clinical evaluation reports. Production quality monitoring. Regulatory change assessments. Market authorization renewals. Line extensions and redesigns.
Innovation
From Concept to Cleared Product
Exalta supports MedTech companies that need a single partner for new product design, development, manufacturing, and regulatory services. Our approach is scalable and flexible. Innovation is driven by customer, clinician, and patient needs in collaboration with key opinion leaders and surgeons.
- Engagement: Define unmet clinical needs and market gaps
- Conceptualization: Align on requirements, timelines, and regulatory needs
- Innovation and Design: Define outputs, perform verification testing, manage IP
- Go-to-Market Readiness: Manage regulatory approval pathways across jurisdictions
Track Record
Certifications and Compliance
150+
FDA Clearances
30+
Global Registrations
250+
Patents Issued
100+
End-to-End Launches
55+
R&D Engineers
Start a Partnership
We work with MedTech companies that need integrated support from development through scalable manufacturing. If your organization is looking for a partner to accelerate innovation and reduce time to market, get in touch.
Trusted by Leading MedTech Companies
