Morrisville, NC—TriE Medical, Inc, a privately held medical device development company located near the Research Triangle Park, is proud to announce that the organization has received ISO 13485 certification for its Quality Management System.
TriE’s scope of registration includes contract design, development, engineering and contract manufacturing services related to mechanical, electrical and software related needs of the medical device industry. TriE has followed a detailed quality management system for years, however we made the corporate decision to obtain certification for our quality system as it was important to our customers and employees. ISO 13485 certification is an important milestone and attests to the quality of TriE’s design and documentation services.
“I am pleased to announce our ISO 13485 certification, it is a true testament of TriE’s dedication to the highly regulated medical device industry and the importance of quality throughout the total product life cycle.."---John Popow, President
About TriE Medical, Inc.
TriE Medical is a medical device and development firm with extensive expertise in therapeutic ultrasound, infusion pumps, respiratory devices, gas delivery systems, drug delivery systems, biomedical monitoring devices, invitro diagnostic devices, and cardiovascular devices. TriE works with our clients to develop medical devices along any stage in the design process while maintaining documentation to meet FDA approvals. TriE’s clients range in size from start-up, mid-size, to multinational companies.
