Medical Devices Quality Management Systems ISO 13485
Medical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. As such, they demand high criteria. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices.
ISO 13485 medical devices quality management system 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.
- Increase the probability of making safe & effective medical devices
- Meet regulatory requirements
- Meet customer expectations
- Increase Efficiency
- Cost Savings
- More Effective Risk Management & Quality Assurance
- Due diligence