Results for tag: "FDA Medical Device QSR"

The FDA Medical Device Quality System Regulation (QSR) is a set of regulations that govern the design, manufacture, and distribution of medical devices in the United States. The QSR is designed to ensure that medical devices are safe and effective for their intended use. The QSR requires manufacturers to establish and maintain quality systems that include design controls, production and process controls, and post-market surveillance. The QSR also requires manufacturers to document and report any adverse events associated with their products. The FDA Medical Device QSR market is highly competitive, with a wide range of companies offering products and services to meet the needs of medical device manufacturers. Companies in the market include medical device manufacturers, contract manufacturers, quality assurance and regulatory consultants, and software providers. Examples of companies in the market include Medtronic, Johnson & Johnson, Stryker, Becton Dickinson, and Abbott. Show Less Read more