ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.
Its an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
Safety and performance of medical devices are paramount in this highly regulated industry, ISO 13485 can help organizations involved in any part of a medical device’s life cycle:
Benefits:
- Demonstrate compliance with regulatory and legal requirements
- Ensure the establishment of Quality Management System practices that consistently yield safe and effective
- medical devices
- Manage risk effectively
- Improve processes and efficiencies as necessary
- Gain a competitive advantage
