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 can act as the “Legal Manufacturer” for your product under our ISO13485:2016 certification and FDA site registration. 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 and achieve market release up to 9 months faster than going it alone. Within our QMS ZIEN can take your product from concept to commercialization in a proven system and get you to market faster and with less cost.
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 and into your future to ensure you succeed.
ZIEN now provides contract packaging and sterilization services allowing improved time to market and decreased investment in these very costly validations. Whether we manufacture your product or we simply help you through these final steps in the manufacturing process ZIEN can save you investment and months of time.
ZIEN currently provides manufacturing services at our two locations to our customers under our QMS and within our two ISO Class 7 capable clean environments. Whether we manufacturer for you or help you outsource we bring our expertise and attention to detail to the process. We continue to expand and invest in our manufacturing capabilities to better serve our customers.
Whether prototyping or production ZIEN can provide laser cut tubing or sheet on stainless steel, nitinol, titanium, or tantalum as well as various processing of these materials under our QMS
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
standards.
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.
