/// Providing the highest level of excellence in our products and services

Quality Assurance

Biosonix manufactures products that exceed our customers expectations. As a team, we continually strive to perfect our processes and products and provide superior service to our customers.

Biosonix is ISO-13485 certified specializing in the Design, Development and Manufacture of Ultrasonic Fluid Sensing, Surgical, Therapeutic and Related Devices.

Biosonix Registrations

  • Biosonix: ISO-13485
  • Biomerics: ISO-13485, ISO 9001, CE Mark & FDA Registered

Problem Solving Tools

  • Six Sigma Problem Solving Tools (DMAIC, 8D)
  • Lean Manufacturing Tools (5S, SMED, 7 Wastes)
  • Value Stream Mapping/Work Flow Diagrams/Process Mapping
  • Visual Management Systems (VFM)
  • 5 Why's, Ishikawa Diagrams, Root Cause Analysis

Product & 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
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