GN ReSound, part of the GN ReSound Group, is one of the world’s largest manufacturers of hearing instruments and diagnostic audiological instrumentation. The primary goal of the company, which has subsidiaries in 23 countries, is to improve the quality of life for people with hearing loss.
As a medical device manufacturer, GN ReSound must meet stringent US Food and Drug Administration (FDA) product data control regulations. After several international mergers and acquisitions, GN ReSound also needed to align and streamline its product data management processes, so it could share product information worldwide and assure FDA compliance.
To achieve these goals, the company implemented Oracle’s Agile Product Collaboration. It consolidated all product data and relevant documentation in a central repository, which acts as a single point of truth for all offices and allows the company to meet FDA regulatory requirements. It also provides a foundation for a global, change-control processes and supports master data for the manufacturing, budgeting, and auditing of product compliance.