Capabilities
In addition to our capabilities as an "integrator" for medical device startups, ZIEN Medical Technologies provides an array of design and contract manufacturing services within an ISO 13485 compliant quality system. With a depth of engineering and quality systems experience, ZIEN has the product and process development expertise to create your solution.
Our capabilities include the following:
01
Design Control and Regulatory Services
02
Business, Design, and Development Planning
03
Contract Packaging and Sterilization
04
Manufacturing and Assembly Operations
05
Laser Cutting and Nitinol Processing
06
RF Tipping and Welding
07
Process Development and Validation
08
Equipment Design and Qualification
As part of our development services, ZIEN provides equipment design and all qualifications necessary to fulfill regulatory requirements. Where appropriate ZIEN performs design and qualification in-house and can manage vendors to the same standards.
Our Strategic Partnerships
ZIEN has selectively chosen to partner with organizations that allow us to facilitate 'Concept to Global Launch' capabilities.
See Partnerships