Quality Assurance

We ensure consistent delivery of products and services that meet the requirements of our customers and strive to achieve complete customer satisfaction while pursuing continuous improvement.

Our objectives are:

• Retain manageability of the business processes
• Prevent nonconformities or detect them at an early stage
• Enforce and continuously improve the effectiveness of the quality management system

In this light to implement on-the-job training, training pertaining to relevant procedures and work instructions, monitoring and enforcement of what has been learned in practice is of great importance. As a result our entire staff accepts and understands how to work both effective and efficient to serve our market.

All our products are class I, non-sterile medical devices and manufactured in accordance with the EN ISO 13485:2016 standard.

A declaration of conformity is available upon request to declare that the products:

• meet all the requirements of the Medical Device Regulation (Regulation (EU) 2017 745, MDR) which apply to it;
• are manufactured in accordance with the appicable standards;
• are subject to quality controls prior to the release of each lot.

Certificate EN ISO 13485_2016