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OEM TECHNOLOGY - CRI Capabilities
- Compliance to FDA QSR 21 CFR Part 820,
Quality system regulation & ISO 13485:2003, Medical devices.
- Engineering & Design
- Ultrasonic Welding
- RF Welding
- Plasma Treatment
- Pad Printing
- Heat Forming
- Balloon Bonding
- Insert Molding
- UV / CA & Solvent Bonding Techniques
- Design for Manufacturing (DFX)
- Quality
- Statistical Sampling Techniques - AQL
- Process Capability Measurement - CPK
- Profile Projector
- Instron Tensile & Compression Tester
- Digital Micrometer
- Supply Chain Management (Product Life Cycle)
- Project Management
- Device Review
- Document Review
- Manufacturing Transfer
- Inventory Transfer
- Inventory Control
- Project Cost Estimates
- Budget & Delivery Tracking
- Customer Service
- Customer Focus
- Proactive Communication
- 99% On Time Delivery
- Validations (IQ/OQ/PQ)
- Sterilization (ETO / Gamma) Including Validations
- Class 8 Clean Room Facility
- Cost Containment
- Responsive Management Team
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