ISO 13485:2016
MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM
One of the medical device industry’s most widely used international standards for quality management is ISO 13485. The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.
Benefits of ISO 13485:2016 Medical Device - Quality Management System
Better Risk Management
Systematically examine the organization's risks management process, taking account vulnerabilities and impacts, and improvise on quality.
Higher conformance to regulatory requirements
ISO 13485:2016 specifies where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and applicable regulatory requirements
Improved Public Perception
With proper systems in place, the contribution towards Medical Device Quality Management System helps in improving the public perception
Optimal Controls and Monitoring
Organizations can be involved in one or more stages of the lifecycle. This standard helps in better monitoring and control.
AXIA ADVANTAGE
Axia Cert International certification process adds more value to your organization through focused audits. The auditors are specifically trained to identify shortcomings in relevance to the global standard requirement. This helps the management to have better insights and control over the organization.
