ISO 13485:2016
MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Benefits of implementing ISO 13485 Management System
- Global Recognition Improved legal and regulatory or contractual requirements compliance
- Assistance in monitoring supply chain effectiveness
- Increased profit margins
- Improved product safety
- Increased Efficiency
- Proactive error detection and prevention
- Cost Savings
- More Effective Risk Management
- Increased likelihood of meeting Customer Requirements