ISO 13485 Medical Devices Quality Management System
ISO 13485 Medical Devices Quality Management System
ISO 13485 Medical Devices Quality Management System is the most widely applied internationally accepted standard for quality management in the medical device industry. The ISO 13485 standard provides the basis for compliance with the EU Medical Device Directive (MDD), the EU Medical Device Directive (MDR) and other relevant regulations. In general, it aims to produce medical devices in a safe and high quality manner.
Requirements of ISO 13485 Medical Devices Quality Management System:
- Quality Management System Installation
- Determination of Management Responsibility
- Control of Resource Management
- Planning and Production of the Product or Service in the Production Phase
- Measurement, Analysis and Improvement
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