Establish a sound quality management system

Normative references of the company's system are as follows:

1) EN ISO 9000:2015;

2) EN ISO 9001:2015;

3) EN ISO 13485:2016;

4) “Regulations on the Supervision and Administration of Medical Devices”;

5) “Measures for the Supervision and Administration of Medical Device Production”;

6) “Good Manufacturing Practice for Medical Devices”;

7) National laws and regulations;

8) Various company regulations;

9) “Regulation (EU) 2017/745”;

The company has been in the process of CE certification and ISO13485 since March 2023.