QUALITY
Making it right, even when no one is looking.
Biosonix manufactures products that exceed expectations. As a team, we continually strive to perfect our processes and products and provide superior service to our customers.
Biosonix specializes in the design, development, and manufacturing of ultrasonic fluid sensing, surgical, therapeutic and related devices. Our quality management system is ISO 13485:2016 certified.

REGISTRATIONS
ISO 13485:2016
FDA Registration Number: 3015508607

PROBLEM SOLVING
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
