ISO 13485: 2016
Medical Devices Management System
A medical devices management system (MDMS) is a set of processes and procedures that ensure the quality, safety, and effectiveness of medical devices. It is designed to help organizations meet regulatory requirements and provide patients with safe and effective medical devices.
ISO 13485:2016 Overview
ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for organizations that design, develop, manufacture, install, or service medical devices. It is designed to help organizations ensure the quality of their medical devices and comply with regulatory requirements.
The benefits of ISO 13485:2016 registration
- Improved quality of medical devices
- Increased customer satisfaction
- Enhanced market access
- Reduced risk of recalls
- Reduced costs
- Improved employee morale
More Specific Benefits
- Improved risk management
- Enhanced communication
- Increased efficiency
- Improved documentation
- Enhanced training
- Improved customer focus
Advantages of ISO 13485:2016
- It is a globally recognized standard
- It is based on the principles of continual improvement
- It is flexible and can be tailored to the specific needs of an organization
- It is a cost-effective way to improve the quality of medical devices
ISO 13485: 2016
Conclusion
