Building a few prototypes for a study and manufacturing thousands of medical products a month are two different things. We are well aware of the challenges that come when transferring a design to manufacturing. All the processes that we develop go through an initial scoping study where we gather data and characterize the process output. We focus our efforts on designing a process that is robust, repeatable, and cost effective. We design our own fixtures and automated equipment.
Every manufacturing process has inherent variability coming from the design of the process itself, the inputs of the process and the operating environment. We utilize Design of Experiment methods (DOE) and statistical process control methods (SPC) to define and validate the operational window of all the processes that are required to be validated, before transferring to production.
Pilot Manufacturing and Design Transfer
Our ISO certified Class 8 Controlled Environment Room (CER) can support your packaging and sterilization validation runs, clinical trials and pilot production runs. If you decide to take the manufacturing in-house or to an off-shore partner, we will prepare the documentation package and ensure the training of all your personnel to suit your needs.
Our Quality Assurance lab supports all our activities, from incoming inspections to final check of outgoing products. We utilize state-of the art automated video measurement Smartscope™ system, and latest generation material testing Instron™ system. Quality is the backbone of our industry and is the top priority of every job we do.