Quality Management Systems for Medical Devices
With their sole focus on being a contract manufacturer of medical devices, Phase 2’s Quality Management System (QMS) has helped to establish the company as a provider of quality medical devices manufactured in a lean production environment.
Phase 2 is FDA registered and ISO 13485:2003 and ISO 9001:2008 certified. Their lean production lines allow an operator to focus on one product at a time, meaning that quality inspection happens real-time as an in-line requirement instead of having to do a post-manufacturing inspection. This puts the responsibility of quality manufacturing squarely on the shoulders of their team of operators, which is comprised of individuals who average 15 years of experience in QMS. Floating quality inspectors are also present to catch something that may have been missed.
Contact Phase 2 for more information on their Quality Management Systems capabilities and see if they might be an ideal choice for manufacturing your next medical device design.