Results for tag: "ISO 13485"

ISO 13485 is an international standard for medical device manufacturers that outlines the requirements for a quality management system. It is based on the ISO 9001 standard, but with additional requirements specific to the medical device industry. The standard is designed to ensure that medical devices are safe and effective for their intended use. It covers the design, development, production, installation, and servicing of medical devices. The ISO 13485 market is a growing sector of the medical device industry. It is a key component of the regulatory framework for medical device manufacturers, and is increasingly being adopted by companies around the world. Companies in the ISO 13485 market include medical device manufacturers, suppliers, and service providers. These companies must meet the requirements of the standard in order to remain compliant with regulatory requirements. Some of the companies in the ISO 13485 market include Johnson & Johnson, Medtronic, Stryker, Becton Dickinson, and Philips. Show Less Read more