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Medical Devices

Implementation of Quality Systems

Companies consider that the ISO 13485 certification is a direct economic cost; however, the implementation and certification of a quality management system should be considered as an investment, which will translate into economic benefits for the company over time, provided that the quality management system is well implemented and applied, thanks to:

  • Improving the effectiveness and efficiency of the organization and, therefore, production costs by reducing time losses in management and implementation of processes.
  • Errors that could lead to non-conforming products, customer complaints, etc., are avoided by improving communication and process control.
  • Improves the perception of the degree of compliance with requirements, thanks to the establishment of quality and process indicators.
  • It allows access to new customers in other countries and, therefore, increases business, as it is a certification recognized in all countries.
  • It gives confidence to customers by having the quality management system certified.

In Azierta we can help you in the preparation of the necessary documentation for the certification of your quality management system by

  • Support, elaboration and adaptation according to ISO 13485.
  • Support for the adaptation in software validation SO/TR 80002-2.
  • Carrying out internal audits.
  • Support in the certification audit.

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience


Leading innovation

Client oriented

100% client oriented


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