Design Control and Regulatory Services

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.

Business, Design, and Development planning

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.

Contract packaging and sterilization

ZIEN provides contract packaging and sterilization services allowing improved time to market and decreased investment in these very costly validations. ZIEN offers an ability to adopt your product into our sterilization cycle which expedites the process to achieve a qualified sterilization cycle to support regulatory clearance. This can save a minimum of 10months of time to launch. We also offer a series of ‘off the shelf’ packages that we can qualify your product into with data supporting sterile barrier life out to 5 years. 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.

Manufacturing and Assembly Operations

ZIEN currently provides manufacturing services at our two locations to our customers under our QMS and within our three ISO Class 7 capable clean environments and our additional two ISO Class 8 capable processing rooms. 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 and now offer ultrasonic welding, heat staking, laser welding, and various bonding technologies. If your device needs attention to detail our team is able to ensure your product meets the most rigorous requirements.

Laser Cutting and Nitinol Processing

Whether prototyping or production ZIEN can help you achieve laser cut tubing or sheet on stainless steel, nitinol, titanium, or tantalum as well as various processing of these materials under our QMS and with our existing processing vendors selected specifically for their attention to quality. 

RF Tipping and Welding

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.

Process Development and Validation

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. Our process validation strategies are designed to improve process consistency and prevent field failures reducing risk to your business.

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.