On May 26, 2020, the new European Medical Device Regulation 2017/745 (MDR) entered into force.
Our company is a proud holder of the certificate for the production of medical devices of this valid European regulation.
This is a new European regulatory policy in this area, which is very demanding. The entire certification process took more than a year, the requirements for the set of technical documentation that we have to submit are high and we will have to properly maintain it for all medical devices.
Other processes will also be much more audited and it is absolutely necessary to follow the established procedures. This certification is crucial for our company, as without its implementation it would be practically impossible to sell our products to healthcare facilities.
The implementation of certification for the production of medical devices according to the European Regulation 2017/745 (MDR) in our processes is a guarantee of the highest quality and compliance with the established standards that are required for medical devices.
You can rely on our products without compromise.
15. 01. 2024