Speed-to-Launch
Parallel development, regulatory, and manufacturing workflows help move programs to launch in as little as 6 to 12 months
Accelerate your path to market
Integrated OEM Solutions
A fully integrated partner that brings development, regulatory, and manufacturing together under one accountable model, removing the complexity of managing multiple vendors.
Why Integrated OEM Solutions
Accelerating Launches through Partnership
Changing how programs move forward, from innovation to readiness
Built-in Accountability
A single, integrated model ensures clear ownership and aligned decision-making across every stage of the program.
No handoffs, no gaps
Development, regulatory, and manufacturing operate as one continuous system, reducing friction, rework, and misalignment between teams.
Regulatory-Ready
Programs are structured with regulatory strategy, documentation, and validation built in from the start, not added later.
Designed as a system
Implants, instruments, and trays are developed together as one system to improve clinical flow, supporting both surgeon performance and patient care.
Faster path to commercialization
A connected model shortens the transition from development to market entry, enabling earlier adoption and helping unlock revenue sooner.
What’s included
- Regulatory strategy and submission planning aligned to intended use, claims, and jurisdiction
- Technical documentation support, including risk management, verification and validation planning, and evidence mapping
- Guidance for platform-based configurations, extensions, and new indications
- QMS alignment to support audit readiness and global approvals
Regulatory and Quality
Regulatory strategy built into development
Regulatory planning is built in from day one.
Development is aligned with 510(k) and EU MDR expectations from the start, with documentation, testing, and validation strategy built into the model.
How It Works
A connected, end-to-end approach
Bringing development, regulatory, and manufacturing together for turnkey systems, with precision production at scale and on schedule.
Create
Whiteboard to concept
Clinical inputs, VOC, feasibility
Design
Engineering and platforms
Technology bricks, platforms, IP
Build
DFM and production
Process dev, tooling, validation
Clear
Regulatory strategy
510(k), CE-MDR, technical files
Launch
Market entry
Commercialization, market access
Scale
Growth and supply
Volume production, post-market
Integrated OEM Solutions
Turnkey systems
The Integrated Model
From Concept to Launch, Without the Gaps
Design, regulatory, manufacturing, and validation aligned from day one.
INPUTS
EXALTA CORE
END MARKETS
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Inputs
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Industrial + Mechanical Design
Early design inputs help shape device requirements, usability, manufacturability, and the path to launch.
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Clinical Insights
Surgeon and KOL input help align implants, instruments, and trays with how products are used in the OR.
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Testing
Testing inputs help validate design choices, reduce late-stage surprises, and support regulatory readiness.
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Precision Manufacturing
Manufacturing input helps align design intent with process capability, scalability, and repeatable production across the EXALTA network
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EXALTA Core
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System Development
Implant, instrument, and tray systems developed together to support procedural use and launch readiness.
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Program Management
Single accountable program team drives schedule, cost, and risk from concept to launch.
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Regulatory Strategy
510(k), PMA, and EU MDR pathways planned in parallel along with development. Not after.
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Verification & Validation
Integrated V&V planning and execution help confirm product performance, usability, and readiness for submission or launch.
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Sterilization
Packaging & Sterilization strategy backed by microbiology support help prepare programs for validation, clearance, and market release.
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Regulatory Trust
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ISO 13485
Quality management systems aligned with medical device development, manufacturing, traceability, and compliance.
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FDA 510(k)
Regulatory support for U.S. market pathways, including testing strategy, documentation, and submission readiness.
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EU MDR
European Medical Device Regulation expertise across technical files, clinical evaluation, and CE marking readiness.
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ISO 17025 | Microbio Lab
In-house accredited microbiology laboratory supporting bioburden, endotoxin, cleaning validation, and sterilization readiness.
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End Markets
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Spine, Extremities & Trauma
Fusion, fixation, and extremity platforms across core orthopedic applications.
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Sports Medicine
Instrument, implant, and procedure-specific solutions supporting arthroscopy, soft tissue repair, and sports medicine systems.
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Cardiothoracic
Sternal closure, thoracic fixation, and instrument systems built for precision and procedural reliability.
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ENT (Ear, Nose & Throat)
Burrs, blades, flexible shafts, and specialty instruments built for ENT and sinus procedures.
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Enabling Technologies
Navigation-ready instruments, robotic components, and smart systems built for next-generation procedural platforms.
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Inputs EXALTA Core Regulatory Trust End Markets
Ready to explore an integrated OEM partnership?
Whether you need a full product lifecycle partner or support for a specific development phase, our team is ready to discuss how EXALTA can accelerate your next product launch.