When Performance Matters
Custom design, manufacturing, and fulfillment of medical cable connections
From concept and design to production and supply chain
Led by senior engineers from Carlisle and Amphenol, our product development, engineering, quality, operations and sales teams are focused on meeting and exceeding the unique requirements of our customers.
By benefiting from a wide selection of connectors and components ready-made for patient monitoring system, Orantech offers significant savings for the customers on OEM projects.
Our collaborative process involves six phases for targeted production:
Six Phases
T0: New Opportunity
• Requirements Gathering
• Needs Analysis & Assessment
• Stakeholder Alignment
• Quotation
T1: Design and Development Planning
• Verify Technical Specifications
• DFM Review
• Stakeholder Alignment
• Establish Specifications
• MVP Generated
T2: Product and Process Development
• Flow chart/PFMEA/SOP/QCP
• Prototype
• DVT Plan (In-house/3rd Party)
• DOE & PV Protocol (IQ/OQ/PQ)
• TMV Protocol
• Customer Approval
T3: Verification and Validation
• Equipment/Fixtures Qualification
• Component Qualification (FAI)
• Component Inspection Plan
• Report (DVT/TMV/PV/MVP)
• Customer Approval
T4: Production
• Training
• Assembly FAI
• Production Approval
T5: Mass Production
• Ramp up Plan
• Change Control Management (ECN/PCN)
• Cost Saving Proposal
• Customer Approval
• Satisfaction Assurance
Development and design
Orantech works in partnership with its customers throughout the development process, bringing a breadth and depth of expertise and solutions to solve the most complex challenges. Orantech provides expert teams in design, engineering, quality, and project management to help you deliver innovative products to the marketplace.
Electro-Mechanical Assemblies
Connector, Contact and Cable Design
Injection Molding, Over Molding and Insert Molding
Mold Flow Analysis
Testing and Verification
Cleaning Requirements & Validation
Product Qualification
Labeling and Unique Device Identification
Manufacturing solution
Based in China facilities with FDA registration and ISO 13485:2016 certificated, Orantech offers wide options to meet your specific requirements and support an extensive range of customized product solution in high or low volumes efficiently, from components and kits to design and certification.
Injection Molding/Over Molding/Insert Molding
Cable & Wire Harness Assembly
Ultrasonic Welding/Crimping/Soldering/Adhesive Bonding
Custom Tooling for precise performance in production
In-process Inspections to ensure superior quality build in workmanship
Process Development/Fully Validation (IQ/OQ/PQ)
Laser Marking and Labeling
Lot Control and Traceability
Supply chain
Medical device manufacturing requires continuous optimization of innovation, risk management, supply, and cost. Safety, quality, on-time delivery, continual improvement, and maintaining the effectiveness of our business management system is achieved through teamwork.
Purchasing Controls
Design and Change Controls
Value Analysis & Value Engineering Process
Schedule Production
Vendor-managed Inventory
Measure Logistics and Service Excellence
Process Validation/MSA executed at vendor facility
Quality assurance
At Orantech, Quality Assurance is a critical part of the process. Compliance, Customer satisfaction, and meeting all applicable requirements is the responsibility and commitment of all Orantech employees.
FDA Registered Facility
ISO:13485:2016 Certified
CE Mark and FDA 510K approved products
Compliant with applicable National and International Regulations
In house Testing and Verification Process
Qualification and Validation
In house TMV (GR&R) Process
Protocol and Report Approval
Continuous Improvement through Plan-Do-Check-Act Methodology
Contract manufacturing services
When you partner with Orantech, you’re connected to an expert manufacturer with diverse resources to manufacture your product at any scale required. We incorporate a formalized program for tracking customer documents, revisions, and updates to ensure customer-authorized change control and unit-to-unit repeatability between production runs.