At SSI Medical, quality is the foundation of everything we do. As a leading manufacturer of disposable medical sensors, we adhere to the highest industry standards to ensure the safety, accuracy, and reliability of our products. Our quality management system is built on rigorous regulatory compliance, including adherence to ISO 13485 and FDA requirements, ensuring that every electrode we produce meets strict performance and safety criteria. Through continuous improvement, advanced manufacturing processes, and comprehensive testing, we provide healthcare professionals with trusted, high-quality medical solutions that enhance patient care.

SSI supports our customers with the following accreditations and services:

QMS & Accreditations

  • ISO-9001
  • ISO-13485
  • ISO-14001
  • FDA Registration

Product/Process Controls

  • Process Validation Reporting
  • Process Risk Assessments
  • PPAP and FAI Documentation
  • Full Component, Equipment, Personnel Traceability
  • Batch Record Submissions and Record Retentions

Infrastructure

  • Class 1000, 10,000, and 100,000 Cleanrooms
  • GMP Protocols
  • Bio-burden Monitoring

Testing

  • EC-12 Testing Capabilities
  • Custom Functional/ Electrical Testing
  • Video Measurement Equipment for Precise Dimensional Analysis
Manufacturing Quality at SSI
Manufacturing Quality at SSI
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