Oxus is an engineering, manufacturing, and service company specializing in medical devices and gas separation technology. We design and manufacture our products in Lake Orion, Michigan. As an ISO 13485 certified and FDA registered OEM supplier, we understand the technical challenges of product realization. We have supported our customers in bringing to market an assortment of challenging products; from industrial design and engineering, through process design and manufacturing.
The medical device industry operates under strict oversight, and the recent release of the FDA’s final guidance on remanufacturing of medical devices represents a very important development for manufacturers, service providers and component suppliers. This article explores the key elements of this guidance, its implications for the industry, and how companies like Oxus are leading the way to ensure compliance.