GE Healthcare

Excellence award

ISO Certified

13485:2003

ISO Certified

9001:2008 with AS9100C

GE Healthcare

Excellence award

ISO Certified

13485:2003

ISO Certified

9001:2008 with AS9100C

Life Sciences

TSS: Life Sciences and Medical

TSS is proud to serve the life sciences and medical equipment industry as a manufacturer of medical systems for over 15 years. TSS is a provider of sophisticated imaging systems to the world’s top medical device companies. TSS strives to enhance the quality of life of those who rely on our customers’ devices by ensuring our products are manufactured to exacting tolerances and our policies and procedures meet or exceed State and Federal requirements.

Certifications

Certifications and registrations include
  • ISO 13485:2003 compliant (Also ISO 9001:2008)
  • Compliant to FDA (QSR) 21 CFR Part 820
  • Registered with the FDA to provide medical scanning and physical testing devices. (Registration number available upon request)
  • Licensed by the Ohio Department of Health to purchase and possess Radioactive Materials.
  • GAMP Guidelines
  • DQ/IQ/OQ/PQ

In addition to our ISO 13485 quality standard, TSS will ensure the highest quality level throughout our manufacturing processes. This enhances our value to support medical customers by shipping products manufactured at TSS directly to the customer’s end user location.

Capabilities

  • Medical Device Assembly
  • Catheter Assembly & Testing
  • Biological Elements Assembly and Test
  • Reagents Handling
  • Insulin Delivery Device Assembly and Test
  • Cannula Inspect and Assembly
  • Micro Fluidics Handling
  • Surgical Robot Assembly
  • Surgical Instrument Assembly
  • Diagnostic Device Assembly
  • Syringe Assembly
  • Kit Assembly
  • Vial Filling
  • Lab Automation Integration
  • Robotic Assembly Automation
  • Custom Automation

Radio-Nuclides

We keep the following Radio-Nuclides on site for testing and calibration:
  • Cobalt-57 – Extended area sources used to generate extrinsic uniformity correction tables for Gamma Cameras. Line sources used to measure spatial resolution for Gamma Cameras. Point sources used to generate energy calibrations for Gamma Cameras.
  • Cadmium-109  – Point sources used to generate energy calibrations for Gamma Cameras.
  • Sodium-22  – Point sources used to measure spatial resolution and establish volumetric uniformity response for PET systems.

Radio-Isotopes

We keep the following Radio-Isotopes on site for testing and calibration:
  • Germanium-68 – Rod sources used to generate response calibration, spatial resolution and uniformity correction in PET systems.
  • Selenium-75 – Point sources used to generate energy calibrations for Gamma Cameras

Examples of Products

  • PET systems
  • SPECT Systems
  • CT Preclinical Systems
  • Digital Mammography/ Molecular Breast Imaging Systems
  • Rehabilitative devices
  • X-Ray Systems
  • Automated blood sample processing machine
  • Automated blood specimen collection
  • Skin Graft Equipment – new method for processing skin graft
  • Neonatal Care

TSS Services

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