Medical Services Manufacturing (ISO 13485)

ISO 9001:2008 Certified Company
To harmonize the medical services manufacturing regularity requirements, ISO 13485 is developed with ISO 9001 base. 

ISO 13485 is also applicable for all organization involved in medical devices business from manufacturing to delivery with the additional CE marking requirements depending on the category of medical devices. 

Processes Improved by ISO 13485

ISO 13485 Medical Devices Management Standard emphasis on: 
  • Proper implementation of quality management system for safe product development and realisation by adopting Risk Management approach.
  • Regulatory and statutory compliance. 
  • Efficient product traceability and recall system. 

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