Quality System at iVascular was implanted on August 2011. First product to obtain CE Mark was PTA balloon catheter oceanus 35 on July 2012. Only 3 years after, iVascular holds CE Mark for 13 different products and 795 references in Interventional Cardiology and Interventional Radiology.

Our Quality System is supported onto three main pillars: the person, the technology and the methodology. Personnel at iVascular is meticulously trained to achieve the highest level of technical knowledge and teamwork. Secondly, technology is our vehicle to develop optimal tools of manufacturing and control. Finally, the success of implementation of the right methods to achieve our objectives depends on requirement and thoroughness.


The range of action of our Quality System covers all the steps involved in our project of vertical integration: design and development, production, and post-commercialization surveillance:

Design & Development

  • Specifications of raw materials
  • Industrial design of the product
  • Verification of achievement of the technical standard, to ensure safety and functionality of the product
  • Validation to ensure proper use of the product according to the intended purpose
  • Risk analysis of the product
  • Definition of processes of manufacturing and control


  • Instructions of operation
  • Methods of control
  • Technical specifications to accomplish
  • Intermediate quality control
  • Final quality control (100% of production)

Post-commercialization surveillance

  • Vigilance system: all complaints and incidents are evaluated to determine the cause and to implement corrective and preventive actions if necessary
  • Clinical evaluation: physician’s opinion is key to continuously improve our products


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