Capabilities
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
Testing
- 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
