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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:

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 medical devices and manufactured in accordance with the ISO 9001:2008 and ISO 13485:2012 + AC:2012 standards. We are entitled to display the CE marking on our products and comply with the requirements laid down in European Medical Devices Directive 93/42/EEC which is mandatory to most of our customers.


ISO Certificate 9001:2008
ISO Certificate 13485:2012 + AC:2012

As proof that the non–sterile and low-risk products are compliant with the MDD, a declaration of Conformity is available upon request.

 

Assosistema Arta DTV TUV Rheinland Member of Afera