ISO 13485 is to facilitate medical device regulatory requirements for quality management systems.It includes some particular requirements for medical devices and excludes some of the requirements of ISO that are appropriate as regulatory requirements. They must present evidence that the device is reasonably safe and specify requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 Certification in India ISO 13485 includes several safety requirements to ensure the quality and reliability of devices created for the medical industry. Although several countries have their own set of regulations by medical device design and creation, the main Quality Management System standard for medical devices.
