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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