Properly supporting the medical industry from a manufacturing perspective requires specialty equipment and processes.  SSI has diligently amassed manufacturing and support capabilities allowing it to meet a very broad range of needs from our medical device clientele.  Whether it’s quality certifications, testing capabilities or manufacturing equipment; SSI has positioned itself to be a versatile and highly capable partner for our customers.

Quality & Regulatory

  • Formal QMS Systems Certifications at multiple facilities including ISO-13485, ISO-16949 and ISO-14001.
  • FDA Registered Facility
  • Process Validation Reporting
  • Process Risk Assessments
  • PPAP and FAI Documentation
  • Full Component, Equipment, Personnel Traceability
  • Batch Record Submissions and Record Retentions


  • EC-12 Testing Capabilities
  • Custom Functional/Electrical Testing
  • Accelerated Aging Testing
  • Video Measurement Equipment for Precise Dimensional Analysis

Equipment & Facilities

  • US-based and Offshore Facilities to  Support Both Small  and Large Volume Production
           (Efficient in Quantities from 10 Units to 1 Million Units)
  • Prototyping (non-tooled) Capabilities
  • Class 1000, 10,000 and 100,000 Cleanrooms
  • In-house  Production Tooling Capabilities
  • In-house Production Fixturing Capabilities
  • In-house Flexible Circuit Manufacturing
  • Laminating and Cutting  Utilizing Multiple Processes
  • Gel Dispensing Capabilities
  • Bio-burden Monitoring
  • Air Tight Sealing Capabilities
  • Custom Packaging Capabilities