Zien Medical Technologies LLC

Zien Medical Technologies is a medical device integrator and contract manufacturer specializing in product development, design control, regulatory compliance, and manufacturing for startups and established companies. The company offers end-to-end capabilities spanning design, engineering, quality systems, manufacturing, assembly, laser cutting, nitinol processing, contract packaging, sterilization, and regulatory affairs. Zien has participated in developing devices across interventional radiology, cardiac surgery, neurosurgery, gynecological, gastrointestinal, acute care, and general surgery specialties. The company acts as manufacturer of record, helping clients navigate FDA 21 CFR Part 11 and ISO 13485 certification requirements to achieve global regulatory clearance. Zien's integrated infrastructure enables startups to accelerate product launches with up to 70% lower development costs and 12–24 months reduction in time to market, eliminating the need for clients to build proprietary facilities or hire full internal teams. The company manufactures and distributes its own branded product lines including SAM Medical (surgical devices), MorTan, and Syntervention products, each supported by digital instructions for use (eIFU). Services include design control and regulatory services, business and development planning, process development and validation, and contract sterilization and packaging operations.