Capabilities

/// Ultrasonic, Injection Molding, Device Assembly, Metrology, and Quality Assurance

Ultrasonic Capabilities

Biosonix specializes in the design, development and manufacturing of ultrasonic sensing, surgical and therapeutic handpieces, and medical device fluid assmblies.

  • Product Analysis, Design and Development
  • Material Selection, Development and Testing
  • Tool Design and Manufacture
  • Testing Services
  • Process Development and Validation
  • Acoustic Performance Analysis and Testing
Ultrasonic Capabilities

Injection Molding Capabilities

We provide contract injection molding services specializing in medical device applications. With over 25 injection molding machines we have the capacity and capability to develop and manufacture a wide range of medical products.

  • 28 Injection Molding Machines
  • Tonnage: 55-950 Ton
  • Shot Size: 25 grams - 20 pounds
  • Platen Size: 12 to 80 inches
  • Support Capabilities
  • Closed Loop Material Drying
  • Centralized Plant Cooling
  • Robotic Automation
  • Molding Technologies
  • Scientific Injection Molding
  • Straight Injection
  • Molding: Structural Foam, Insert, Over, and Intrusion
  • Hot Runner Systems
  • Color Matching
  • Trim and Deflash Operations
  • IQ, OQ, PQ Validations
  • DFMEA, PM, Controls
  • Cleanroom Molding
Injection Molding Capabilities

Medical Device Assembly

Biosonix develops, manufactures, and assembles quality medical devices in our controlled assembly room using both manual and automated processes.

  • Contract Assembly Services
  • Catheter Production
  • Respirator Devices
  • Surgical Devices
  • Sub Components - Imaging
  • Primary Operations
  • Injection Molding
  • Extrusion
  • Assembly
  • Secondary Operations
  • Pad Printing
  • Welding
  • Drilling
  • Painting and Plating
  • RF and Ultrasonic Welding
  • Gluing/Solvent Bonding
  • Soldering
  • Packaging
  • Laser Welding
Medical Device Assembly

Metrology Capabilities

Biosonix offers validation testing and reporting services, device function testing, and inspection and measurement capabilities.

  • Inspection and Measurement Capabilities
  • Smart Scope Vision Measurement System
  • Benchtop Laser Micrometer
  • Optical Comparators
  • In-line Process Inspection
  • Calipers, Scales, Microscopes, etc.
  • Laser Scan Capabilities
  • Ultrasonic Stroke Measurement
  • Plant Wide ISO13485 Calibration System
  • Validation Testing and Reporting Services
  • Incoming Inspection Processes
  • First Article Inspection Reporting
  • OQ and PQ Validations Reporting
  • Continuous Monitoring
  • Device Function Testing
Metrology Capabilities

World Class Labs

Biosonix provides lab services for all of your design and development needs for both materials processes and quality activities.

  • R&D Material Development
  • Incoming Raw Material Certification
  • In-House Material QC
  • Material Characterization Capabilities
  • Ultrasonic Measurement and Data Collection
World Class Labs

Quality Assurance

Biosonix is committed to partnering with our customers to assure that our products and quality systems meet their needs.

  • Registrations
  • ISO-13485 Certified, CE Mark and FDA Registered
  • Product and Process Validation
  • Standard Work Documentation
  • DFMEA / PFMEA / Control Plans
  • First Article Layouts and Approvals
  • Process Capability Studies (CpK)
  • Real-time Monitoring Systems
  • IQ, OQ, PQ Validations
  • Lab Testing for Analysis and Compliance
  • Risk Analysis and Risk Assessment
  • Operational Tools
  • Preventative Maintenance Program
  • Mold Maintenance Program
  • Clean Room Process
  • Calibration Program
  • Regular Internal Audits
Quality Assurance

Capabilities

Design, development and manufacture
of medical ultrasonic transducers
for sensing, surgical and therapeutic
applications.

Technologies

Air bubble detectors, fluid sensing,
ultrasonic handpieces,
sub-assemblies, and
driver boards.

Expertise

Ultrasonic design, analysis and
practical implementation from
piezo electric materials
to complete systems.