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Offered by us are various ISO 13485 Certification in compliance with the demands of our customers. The certification given by us is a global standard that specifies the demand for medical device companies. Our ISO 13485 : 2003 certification has been blended against the three directives (In-vitro Diagnostic Devices, Medical Devices and Active Implantable Devices). The crucial particularity of this certification over the ISO 9001 is that it is more concerned about confirming medical device safety instead of achieving patron satisfaction and constant advancement. This certification has got wide demand as the global standard to meet medical device guidelines.

 

Advantages of ISO 13485:

 

  • Increased efficiency
  • Cost savings
  • More effective risk management and quality assurance
  • An improved ability to respond to customer requirements are just a few of the potential results that certification to the standard can bring
  • Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe

ISO 13485

 

ISO 13485