Whether you are trying to build a new and improved device or a completely new product concept, we can help refine and develop the opportunity with complete support activities to meet the industry requirements.
Quick and effective development of samples needed for bench testing and trials are extremely consequential in the early stages of new device technology. Having the capacity and insight needed for detail, functionality and design exists within the experienced staff and available resources needed to create functional feasibility level samples.
Navigating the pathways within the medical device regulatory boundaries requires the support of someone that has traveled down that path. We have the resources to identify/act on each requirements needed for commercialization.
Our quality management system is designed to support the development and manufacture of any medical device technology requiring adherence to FDA QSR, and ISO regulations. Our operational experience resides in all areas of medical device catheter-based technology.
Our FDA registered facility is ready for whatever level of manufacturing required. From simple OEM bulk component processing to final device assembly, we can accommodate. Our model is set up to accommodate quick turnaround low volume activities and scalable for the support of long term high volume requirements.
Mfg. Process Development
Design for manufacturing and related process development is crucial to the potential for medical device success. Our experienced team has supported the growth and expansion efforts for many years of medical device manufacturing.
The success of any device is directly related to the diligence performed in the early stages of development. We have the experience and expertise from many years of clinical interaction as well as device design concepts needed to meet the clinical needs of new medical device technology.