ISO 13485GET CERTIFIED
Quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities.
- Specifically tailored for the medical devices industry to demonstrate its ability to systematically provide medical devices and services that consistently meet customer requirements, meet applicable regulatory requirements and safety standard.
- Provides a systematic approach to risk management.
- Systematic, smoother, transparent and documented handling of activities required by regulations such as post market follow up and surveillance, complaints handling, process validation, product recall handling, vigilance etc.