Basic principles of ISO 13485  

• Customer and patient safety - focus on safe and effective medical devices.  
• Regulatory requirements - compliance with legal regulations and standards.  
• Risk management - Identification and minimisation of risks throughout the product life cycle.  
• Process-orientated approach - Clear, documented quality control procedures.  
• Traceability - Complete documentation for safe product manufacture.  
• Validation & verification - Careful testing of processes and products.  
• Continuous improvement - Constant optimisation to increase quality and safety.  

This standard ensures that medical devices meet the highest quality and safety standards. 

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Certificate DIN EN ISO 13485