TURNKEY MANUFACTURING SETUP
We build end-to-end implant manufacturing capabilities ISO 13485-aligned-from factory planning to production ramp-up. From process layout design to equipment and machine specification, we transfer our engineering know-how to launch a high-efficiency, stable-quality production operation.
• Factory planning & process layout
• Equipment & machine specification
• Production flow design & capacity ramp-up plan
• Process validation roadmap (IQ/OQ/PQ planning)
• Documentation starter pack (SOP structure)
• Production team training & ramp-up support
PROPRIETARY DESIGN SOLUTIONS
We provide design-led product engineering services that turn requirements into manufacturable, market-ready products. Through product development, reverse engineering, benchmarking analysis, and design optimization, we help you meet performance, compatibility, and cost targets—so you can accelerate market entry with clinically reliable implant and instrument solutions.
• Product development & concept engineering
• Reverse engineering & technical reconstruction
• Benchmarking analysis & competitive evaluation
• Design optimization & performance enhancement
• Design for manufacturing (DFM) integration
• Technical design documentation (CAD)
• Prototype development & design verification
STRATEGIC SUPPLY CHAIN
We manage the complexity so you can stay focused on production and growth. COREVENA secures and supplies critical materials, components, and finished/semi-finished goods with competitive pricing, full traceability, and long-term continuity. We provide supply assurance with commitments of up to 10 years for critical items. Simplify procurement with a single point of contact.
• OEM Supply (Finished & Semi-Finished, Implants & Surgical Sets)
• Industrial Sourcing (Raw Materials, Consumables & Production Supplies)
• Procurement & Logistics Coordination
• Traceability Documentation
• Supply Assurance (10-Year Supply Commitment)
ENGINEERING SERVICES
• Engineering consulting & technical advisory
• Simulation & digital performance analysis
• 3D scanning & reverse data acquisition
• 3D modelling & parametric design development
• Rapid prototyping & functional iteration
• Industrialization planning & scale-up support
• Machine & process setup implementation
• Tooling & fixture design engineering
• Process validation support (IQ/OQ/PQ alignment)
QUALITY MANAGEMENT
• QMS setup & structured documentation architecture
• CE / ISO certification consulting & compliance guidance
• Audit readiness assessment & preparation support
• Validation planning & execution (IQ/OQ/PQ coordination)
• Quality engineering & control plan development
• In-process quality checkpoints & inspection strategy
• CAPA implementation & risk management systems
• Quality metrics tracking & continuous improvement
• Supplier audits & quality agreement structuring
• Customer quality support & technical liaison services
DIGITAL TRANSFORMATION
• Orthopedic-focused manufacturing ERP implementation
• Real-time production data tracking systems
• End-to-end digitized product traceability
• Automated data analytics & big data integration
• Performance monitoring & KPI dashboard systems
• Digitized change management infrastructure
• IT/OT integration & IoT connectivity setup
• Digital twin development & operational deployment
STRATEGY, FEASIBILITY & INVESTMENT
• Strategy & investment planning — execution roadmap & milestone definition
• Investment modeling & financial scenario analysis
• Comprehensive financial assessment & risk evaluation
• Technical & commercial feasibility study
• Investor-ready business plan development
PROJECT MANAGEMENT
• Investment program management & execution oversight
• Capacity expansion planning & implementation
• R&D coordination & product development governance
• New manufacturing capability build-up & commissioning
• New product introduction (NPI) to serial production
• Market launch strategy & field performance support
