Quality Assurance Services
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.
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Services Overview
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.
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