ISO 13485:2016
Medical Devices – Quality Management System
Standard brief
An ISO 13485:2016 certificate creates a global acceptance and reputation for companies in medical sector including manufacturers, storage, semi-finished product and service suppliers provides certification ISO 13485:2016 medical devices quality management system certification services. – medical quality management system with its experienced staff. ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements.
Benefits
- Improve customer satisfaction.
- Improve your processes.
- Improve decision-making.
- Create a culture of continual improvement.
- Better employee engagement.
- Reduced cost of sales
Concepts
- Quality Management System.
- Medical Device File
- Design and Development Process of Medical device
- Medical Device Life Cycle
- Product Traceability – Medical Device Tracking
- Software Integrations of the Medical Device
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