ISO 13485:2016 has recently been revised, with the new version published in March 2016.
ISO is the International Organization for Standardization, a worldwide federation of national standards bodies. It supports medical device manufacturers to maintain the effectiveness of their processes. ISO ensures the development, production, installation, and delivery of medical devices that are effective and safe.
ISO 13485:2016 quality management systems specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that meet applicable regulatory requirements.
The ISO 13485:2016 standard is globally recognized as the best quality practices from organizations within the medical device industry. Due to the nature of the medical equipment, safety is one of the principal requirements.
Realtime Technologies, as a medical devices manufacturer, has a responsibility to deliver devices that are high quality, safe and effective.
Realtime Technologies is an electronics contract manufacturer and services provider. Our extensive engineering capabilities also allow us to manufacture electronics to precise customer specifications and provide a turnkey service. We provide products and services for Medical Analyzers, Pressure Testers and Monitors, Heart Monitors, cardio Analyzers, Receiver Units, and other Instruments. Our 22 years of manufacturing experience are enabling us to solve unusual issues in medical device design.