Quality Commitment & Certifications

World-class medical device development and manufacturing begins with commitment to quality— adhering to our Quality Management System, industry standards and requirements, and the requirements of our customers. We maintain full quality assurance excellence through quality control standards and production process controls. View our full quality assurance certificates below.

Quality Controls and Services

  • Design verification and validation activities
  • Process characterization studies
  • Process validation activities
  • Design transfer activities
  • Ability to hold design history files (DHFs) to ensure GMP compliance
  • Certificates of compliance


Operating to the highest quality standards, as expected for the medical device industry

Manufacturing to ISO 9001:2008 requirements

FDA registered

Design control system compliant with FDA & European regulations

Significant experience with the FDA 510(k) clearance process

OEM Assembly

TE has the global footprint and resources to meet all our customers' needs. Our engineers will collaborate closely with you to transition your product from design to manufacturing. Multiple sites are FDA registered and ISO Certified with cleanroom for a controlled manufacturing environment. Capabilities include:

  • OEM guidewire assembly
  • OEM balloon catheter assembly
  • OEM braided catheters
  • OEM coiled catheters
  • OEM extrusion
  • OEM finished devices

Our 20,000 square foot manufacturing plant in Costa Rica is critical to our ability to support our medical device OEM customers throughout the lifecycle of their products by having a low-cost, high volume manufacturing operation in a free trade zone. TE can support your medical device design and manufacturing needs. Contact us today for more information.

Test and Validate

Quality, reliability, and responsiveness are keys to a successful supplier/OEM relationship. TE performs electrical, mechanical and environmental testing in our in-house labs, 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. Examples include the following:

Environmental Mechanical Electrical
Temperature and Humidity Vibration Low-Level Resistance
Temperature Cycling Physical Shock High-Resistance Measurements
Thermal Shock and Heat Age Tension/Compression Dielectric Withstand
Vaporized Hydrogen Peroxide Tensile/Torsion Temperature Rise vs. Current
Sterilization Withstand Normal Force RFI/EMI
EtO Mate/Demate BERT Testing
Gamma Flex-Life CE
Biocompatibility Crush Resistance Residual Noise

Assembly in FDA-Registered Facilities & Class 8 Clean Rooms

Quality Certification & Audited Processes
  • 21 CFR 820.30
  • ANSI/AAMI EC-53 1995
  • Directive 2002/95/EC (RoHS)
  • IEC 60601-1
  • MDD 93/42/EEC