01 Jul VISARIS CERTIFIED UNDER NEW VERSION OF ISO 13485:2016
Posted at 11:42h
in Uncategorized
QUALITY POLICY
BELGRADE, 1. July 2019.ISO 13485 is the most widely accepted model for regulating quality management systems of medical device manufacturers worldwide. The implementation of the new standards places emphasis on the risks linked to the safety and performance of medical devices and their compliance with regulatory requirements and the demands of customers. Some advantages of adopting the new version of the standards are:
- Additional control by the customer
- Compliance of systems with regulatory requirements
- Applying risk management and planning
- Better clinical tracking of device performances
- Software validation
ISO 13485 standard enables the organization to ensure the delivery of safe and efficient medical devices thus meeting the
demands of regulatory bodies and customers.
