ISO 13485:2016 is a Quality management system required for regulatory purposes. It represents the requirements for a comprehensive quality management system.
The ISO 13485:2016 specifies requirements for a comprehensive quality management system for the design & development, production, storage, distribution, installation, servicing of a medical device where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 13485 standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system. For manufacturers and service providers both comply and demonstrate their compliance with regulatory requirements. The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers.
ISO 13485:2016 Benefits:
- Increase access to more markets worldwide with certification.
- Outline how to review and improve processes across your organization.
- Increase efficiency, cut costs and monitor supply chain performance.
- Demonstrate that you produce safer and more effective medical devices.
- Meet regulatory requirements and customer expectations