Marble Surface

QUALITY POLICY

ISO 13485

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Our objective is to ensure that every product, meets customers and authorized regulatory expectations for quality, safety and efficacy. Our commitment is to create an advanced Quality System applicable across the life cycle of each product through a continuous, in-depth and forward-looking monitoring of the medical devices regulatory environment.

Quality is fully integrated into our business processes, it is seen as a joint responsibility of all personnel and it is achieved by combining the collective ambition and individual contribution at all levels of Agetis.

The quality of our products is assured by the cumulative effect of the sub-contractors we choose, the premises, the equipment, the materials, the services and the personnel involved directly and indirectly in the processes.Our main target is to produce high quality products and meet our customers’ expectations.

 

Therefore, we:

  • Ensure patient safety through risk management, quality assurance of medical devices and compliance with Medical Device Regulation (MDR) 2017/745

  • Seek for the continuously enhancement of customers’ satisfaction

  • Track and apply new innovative technologies

  • Maintain and continuously improve the effectiveness of our Quality Management System ISO 13485:2016 in every aspect of business processes

  • Invest on the continuous improvement of our personnel through continuous training.