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

Medical Disposable Sensors Design Guide

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