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Certification

Quality Management System for Medical Devices

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We offer you a differentiation tool to increase the safety and satisfaction of your customers and users. 

  

In an ever more globalized and demanding market such as the health market, different regions or countries frequently issue new regulations or requirements for the manufacture and commercialization of medical devices. 

 

 

Why certify to IRAM-ISO 13485 standard?

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You will be able to demonstrate to the market that you meet both regulatory requirements and your customers’ expectations, offering health products or devices that respond to every need.  

 

Our certification will open doors to new markets and will allow you to project yourself internationally. 

 

  • Bring safety to the value chain, taking care of the patient’s health. 
  • Access internationalmarkets. 
  • Optimize costs.  
  • Improve your image in front of clients and users 

Our certification allows you to achieve the international IQNet certification.

Looking to implement and certify a management system? Let us explain it to you in this video:

Make our marks visible and build trust

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