As an ISO 13485 certified and FDA registered medical device manufacturer, Interplex Medical excels at providing an optimal level of support for each customer based on their production needs. We provide a seamless transition [from product development into steady-state production] utilizing processes that are continually benchmarked for efficiencies and effectiveness.
Through the use of value-added tools; such as Theory of Constraints (TOC), 5S Methodology and Continual Improvement Processes (CIP), Interplex Medical thinks ‘lean’ right from the beginning.
Each laminar flow Environmentally Controlled Room (ECR) is ISO 14644 Class 8 certified with daily monitoring and quarterly testing.
From prototype and clinical builds, to sterilization studies and beyond…we provide the operational flexibility to support the most unique pilot build programs. Our manufacturing systems are designed in order to manufacture single-piece prototypes and market evaluation builds in preparation for full-scale steady–state production.
Interplex Medical employs a commitment to quality and excellence throughout the organization. By providing continuous training, clear Work Instructions (WI) and constant process auditing, we consistently manufacture defect-free products.
We understand that manufacturing does not end with the completion of the device—packaging and labeling are critical components to any product. Therefore, Interplex Medical begins assessing these needs during the early stages of development [from single-unit pouches and custom thermoformed trays, including EtO, Gamma and E-Beam sterilization] and partners with industry leaders to provide a smooth turnkey solution.
Interplex Medical utilizes a fully-integrated Enterprise Resource Planning (ERP) system to control all phases of planning, manufacturing, purchasing and inventory management. These tools allow us to provide Just In Time (JIT) manufacturing, thereby reducing inventory and holding costs, and passing savings on to our customers.