Kalamazoo, MI — Humphrey Products is proud to announce that it received the accreditation for ISO 13485: 2003 in addition to its continued accreditation of ISO 9001 status. ISO 13485 represents the requirements that medical device manufacturers must incorporate into their management, engineering, distribution and quality systems.
Adding to all the normal benefits that the ISO 9001 registration provides customers and distribution, ISO-13485 certification provides the system controls, serialization, process change controls and notification that are currently required for products used and sold within medical markets.
“The medical market is a huge and all encompassing category and can cover many and varied applications,” said Robert Humphrey, President and CEO of Humphrey Products, “anywhere from process equipment used in the automated preparation and evaluation of biopsy materials on test slides, to those applications such as oxygen concentrators used by the patient within their own homes, or all the way into the ER, and patient invasive devices used by surgeons to assist with various medical procedures.”
Humphrey Products
www.humphrey-products.com
