As you identify the challenging component and sub-assembly requirements for your medical device, there's one name to know: TE Connectivity. Our vast capabilities and proven strength in design and development engineering will take your project from concept to production. Rely on TE to provide innovative solutions through our core technical competencies: wire & cable; custom connectors; heat-shrink tubing; medical molding; and precision mechanical stamping.
The TE advantage continues with our strength in design engineering. With engineers located throughout the world, we are a global design powerhouse. In addition, we combine our expertise in environmental challenges, mechanical stresses, electrical requirements and design control to provide you the overall performance and reliability you require.
At TE, our manufacturing capabilities are vast. We coordinate IQ/OQ/PQ requirements with expertise in material process controls and process development validation to deliver cost-efficient manufacturing for your project. After first article approval, we can quickly ramp into full production in response to your urgent time-to-market needs. Additionally, with our truly global manufacturing footprint, including three priority sites with ISO 13485 certifications, TE can leverage procurement, volume manufacturing, and distribution to your advantage.
Flexible manufacturing allows TE to handle low to high-volume production requirements, as well as a very high range of product and sub-assembly complexity. We understand that safety and effectiveness are critical to the success of your next-generation medical device, therefore our production processes utilize online documentation, process validation and closed-loop process controls.
At TE, our in-house labs perform electrical, mechanical, and environmental testing to qualify and validate designs and to monitor product processes. We test for reliability and performance to your specifications, as well as compliance with identified regulatory and end-user requirements.
TE follows industry standards in the testing and qualification of medical products and materials.
- UL/CSA
- DIN/VDE
- ANSI/AAMI
- IEC
- ISO
In-house capabilities:
Environmental:
- Temperature, Humidity, Temperature Cycling
- Thermal Shock & Heat Age
- Steris®, Sterrad®, Autoclave/Sterilization Withstand
Electrical:
- Low-level resistance
- Dielectric withstand Voltage breakdown
- High-resistance measurements
- Temperature rise vs. current
- RFI/EMI
- BERT Testing
Mechanical:
- Vibration
- Physical Shock
- Tension/Compression
- Tensile/Torsion
- Mate/Demate
- Flex-life
- Normal force (contact retention)
- Crush resistance
Management & Oversight of External Testing:
- Biocompatibility
- EtO
- Gamma Withstand
TE's global manufacturing sites are registered to the necessary international quality management system and regulatory standards to assist you in ensuring that your products are manufactured in compliance with your specified regional, national, and international regulatory requirements.
Our product diversity, engineering expertise, manufacturing experience, and global presence will provide you with the products you require, the turnaround you need, and the distribution scheme you choose. We are a global organization experienced in the medical market and, as your innovative solutions partner, we are committed to your success.
Worldwide Opportunities:
- Complete project managmenent from concept to production
- Global purchasing power and facilities for raw materials
- Dock-to-Stock and Just-In-Time distribution systems
- Vendor managed inventory (VMI)
- Packaging
- Value-add solutions
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