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Resources
Engineering Design/Plastics Technology
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Chemical
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Electrical
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Mechanical
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Plastics
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Polymers
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Materials
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Biomedical
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Software
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Molecular Analysis and Biomarker Discovery
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Bruker Ultraflex II MALDI-TOF/TOF mass spectrometer
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Bruker ClinProt robot for magnetic bead sample preparation
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Micromass Triple Quadrupole mass spectrometer with automated sample handling
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Access to equipment and facilities of equity partner, Cleveland Clinic Foundation
Quality Assurance and Regulatory Reviews
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Quality Engineering – DOE, FMEA, SPC/process capability, corrective/preventative action system
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510(k), EU Medical Device Directive preparation and approval
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ISO 9001:2000, ISO 13485:2003, MDD/CE, CMDCAS, FDA-registered, QSR/GMP compliant, UL-registered
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Certified suppliers
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Sterilization validation and management
Manufacturing
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Rapid prototyping
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Rapid tooling
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Plastic injection-molding
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Tool room services
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High-speed automated assembly
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Precision disposables assembly
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Electromechanical assembly
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Class 100,000 clean rooms
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Ultrasonic welding
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Pad printing
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Ultraviolet bonding
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Solvent/adhesive bonding
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Automatic tube cutting/coiling
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Pouching and tray packaging
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Automatic leak testing
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Automated vision inspection
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