Certifications

Quality and Environmental Policy

 

The main activity of 77 Elektronika Műszeripari Kft. is development, production, distribution and service of medical devices in the domestic and international markets.

 

Our primary goal is to provide our products and services in excellent quality and reasonable price in timely manner in order to increase our customers’ satisfaction in line with the product related regulations.

 

In order to achieve our quality objectives, we implement, operate and develop ISO 13485 and ISO 9001 quality management systems continuosly, as well as we are also committed to adapt the quality system related requirements of the target markets, such as 21 CFR Part 820 (Food and Drug Administration, USA) and 2017/746 IVDR and 2017/745 MDR (European Parliament and of the Council, EU).

Our company focuses on the protection of the environment, prevention of pollution and environmental conscious use of resources. We make effort to mitigate adverse effects to the environment during design and development, production and related processes. In order to achieve this goal we implement and develop ISO 14001 environmental management system continuously.

 

77 Elektronika Kft. is committed to ensure appropriate infrastructural conditions and safe working environment to all employees, therefore established a separate department within the organisation specially for this purpose.

 

We consider the regular training of our employees as a basic requirement in order to accomplish our company goals.


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