The Road to CE Certification: A CardioNS Story

Today, it may seem that bringing the CardioNS device to market was simple. 

In reality, it was not quite that straightforward.

To be placed on the market, CardioNS had to comply with very strict and complex regulatory requirements.

The first aspect relates to its classification as a medical device. In the case of ECG devices, this corresponds to Class IIa. In broad terms, this means that the device poses a moderate risk to the patient and is intended for use over a limited period of time.

Regulatory requirements also apply to the manufacturing process and to the materials used in production. The company PanonIT, in addition to holding several ISO certifications, possesses all the necessary approvals for manufacturing such a technologically advanced medical device.

After production, and before being offered for sale, the finished product undergoes a series of rigorous tests assessing everything from patient and user safety to the accuracy of the device and the reliability of the obtained results. Once all criteria are met, the ECG device is awarded the CE mark, which is a prerequisite for sale on the European market.

During the certification process for the CardioNS mobile ECG, it was established, among other things, that:

✔️It has IP22 protection, which means, protection against objects larger than 12.5 mm and against vertically falling water droplets

✔️ It can be used at temperatures from 5°C to +40°C, with ambient relative humidity between 15% and 90%, and atmospheric pressure from 700 to 1060 hPa

✔️ The radiation it emits is within permitted limits, and even improper use of the system does not result in increased radiation levels

In Summary