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iso 13485 certification
 

iso 13485 certification India ISO 13485: 2003 Quality Management System (Regulatory Requirements for the Medical Devices)

 
  ISO 13485 represents the requirements for a comprehensive management system for the design and manufacturing of medical devices. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. More over, compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.

However, the fundamental difference between the two is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires the organization to demonstrate that the quality system is implemented and maintained.
 
  If you wish to get your company ISO 13485: 2003 certified, please send us an inquiry  
     
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