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Z-Teck News!
Z-Teck News

June 22, 2007

Word for the Wise

"It takes 20 years of hard work to become an overnight success."
--Diana Rankin,
writer and public speaker

Posted by zteck at 07:57 PM
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Z-TECK has more than 25 years of experience performing services for start up companies to large multinational firms, with medical devices, drugs, drug-device combinations, and biological products. Z-TECK provides comprehensive regulatory and quality system assistance to help firms meet domestic and international product requirements. Z-TECK assures high quality, reliability, and integrity in the performance of its services.

Z-TECK has experience working with:
  • Software Driven Medical Equipment
  • Hemodyliazers & Dialysis Equipment
  • Apheresis/Plasmapheresis Systems
  • Hemoperfusion Systems
  • Implantable Drug Delivery Systems
  • Steam and Ethylene Oxide Sterilizers
  • Biological Indicators
  • Surgical Tables & Surgical Lights
  • Sterile, Single-Use, Disposable Devices
  • Powered Muscle Stimulators & TENS Devices
  • Centrifugal Pumps & Cannulae for Beating Heart Surgery
  • Drugs & Biologicals
  • Stem Cell Separation & Preservation
  • Blood Processing Equipment
  • Parenteral Solutions
  • CAPD Systems
  • Sterile Connectology
  • Blood Access, Blood Tubing, and i.v. Sets
  • Blood, Plasma & Cell Freezing Equipment
  • Long Dwelling Catheters
  • Blood, Plasma, and Platelet Bags
  • Medication Applicators
  • Novel Drug Delivery Systems
  • Cardiopulmonary By-Pass Systems
  • Z-TECK can assist you with establishment registration & device listing; premarket applications; CE marking; standards for product safety and efficacy; risk management; good manufacturing practices; complaint handling; MDRs, ADEs, and vigilance reporting; field corrections and recalls; and U.S. Designated Agent.


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