In addition to its 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:
ZIEN has developed equipment capable of rapidly prototyping tipped or welded catheters. This
system is fully capable of being validated for low or intermediate volumes of production.
ZIEN’s staff has extensive experience in process development and validation that can be applied
to your processes to troubleshoot, improve, and validate processes to improve yields or meet quality
ZIEN provides an ISO 13485 Quality System for its customers. Within this QMS ZIEN provides full
design control and regulatory services capable of FDA clearance and CE Marking activities. These
services allow us to develop products for our customers that fulfill all product and regulatory
requirements. Within our QMS ZIEN can take your product from concept to commercialization in a
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.
ZIEN provides a full array of business and design planning services to our customers. ZIEN’s
customers have benefited from business plan development, fund-raising efforts, and development
planning reducing time and cost to market. ZIEN participates as a partner in your company’s financial
health and future throughout the development process.
ZIEN currently provides manufacturing services to our customers. As desired ZIEN can provide
early pilot manufacturing through production within a GMP compliant quality system.