Results for tag: "ISO 14971"

ISO 14971 is an international standard for risk management in the medical device industry. It provides a framework for manufacturers to identify, assess, and control risks associated with their products. The standard is designed to ensure that medical devices are safe and effective for their intended use. It is applicable to all stages of the product life cycle, from design and development to production and post-market surveillance. ISO 14971 is widely used by medical device manufacturers, regulatory authorities, and other stakeholders in the industry. It is an important tool for ensuring the safety and efficacy of medical devices, and is often used in conjunction with other standards such as ISO 13485 and IEC 60601. Some companies in the ISO 14971 market include Johnson & Johnson, Medtronic, Abbott, Becton Dickinson, and Stryker. Show Less Read more