Contract Manufacturing Services

From electrical assembly to probe brazing and buffing, our processes are rigorously defined and continuously improved to provide the highest quality attainable. Our production facility and procedures have been developed to provide the superior product quality and product tracking required for contemporary medical devices. We have implemented processes complaint with global regulatory requirements, including:

  • FDA Quality System Regulation
  • ISO 13485 Quality Management Systems Standard
  • Medical Device Directive

Cybersonics maintains a controlled environment for clean processes such as packaging and sealing as well as sterile product assembly prior to sterilization. This room is controlled by HEPA filtration utilizing laminar air flow principles and the air quality is monitored for particle size and counts.

  • Supplier selection and approval
  • Incoming Inspection
  • Assembly
  • Sterilization
  • Finished Goods inspections and test
  • Product Services & Repair

Contract Design and Documentation Services

Our team of highly qualified electrical, mechanical, and biomedical engineers have the expertise and experience to design and develop complete systems which incorporate all the safety and reliability features required for operation in surgical and other harsh environments. 

Building on our strong foundation of technology, engineering project management and quality manufacturing we offer our customers:

  • Analog on Digital Signal Processing
  • Impedance matching of ultrasonic transducers for power device optimization
  • Control systems
  • Software
  • Chassis Design
  • Labeling 
  • User Interface
  • Risk Analysis and Safety Testing
  • Transducer design
  • Waveguide and End effector design 
    • Cleaning and Sterilization
    • Regulatory Submission
      • FDA 510K
      • CE Mark
    • Verification and Validation Testing