Resources

Engineering Design/Plastics Technology

  • Chemical
  • Electrical
  • Mechanical
  • Plastics
  • Polymers
  • Materials
  • Biomedical
  • Software

Molecular Analysis and Biomarker Discovery

  • Bruker Ultraflex II MALDI-TOF/TOF mass spectrometer
  • Bruker ClinProt robot for magnetic bead sample preparation
  • Micromass Triple Quadrupole mass spectrometer with automated sample handling
  • Access to equipment and facilities of equity partner, Cleveland Clinic Foundation

Quality Assurance and Regulatory Reviews

  • Quality Engineering – DOE, FMEA, SPC/process capability, corrective/preventative action system
  • 510(k), EU Medical Device Directive preparation and approval
  • ISO 9001:2008, ISO 13485:2003, MDD/CE, CMDCAS, FDA-registered, QSR/GMP compliant, UL-registered
  • Certified suppliers
  • Sterilization validation and management

Manufacturing

  • Rapid prototyping
  • Rapid tooling
  • Plastic injection-molding
  • Tool room services
  • High-speed automated assembly
  • Precision disposables assembly
  • Electromechanical assembly
  • Class 100,000 clean rooms

Ultrasonic welding

  • Pad printing
  • Ultraviolet bonding
  • Solvent/adhesive bonding
  • Automatic tube cutting/coiling
  • Pouching and tray packaging
  • Automatic leak testing
  • Automated vision inspection