Health care

Medical device

The AiVoni® -service will be a
Class IIa medical device.

With the help of the service, you will be able to monitor your heart and heart arrhythmia can be diagnosed.

The AiVoni® –service consists of the  following components:  

The AiVoni® –measuring device (electrodes + sensor)

The AiVoni® for Android –application

The AiVoni® –analyses service   

What is a medical device?

According to the Council Directive 93/42/EEC a ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

 

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Diagnosis, prevention, monitoring, treatment or alleviation of disease. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
Investigation, replacement or modification of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices
Providing information by means of in vitro examination of specimens derived from the human body
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and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

The journey of a medical device

Before a medical device can be legally marketed (sold) in the European Union, a CE Mark certificate is needed. This certification verifies that  the device meets all regulatory requirements for medical devices.

Years of research and clinical validation is needed before the device can be audited and certified. Finland has a few Notified Bodies, conformity assessment bodies, that have been designated to carry out conformity assessment according to EU regulations, and that can issue certificates. If changes are made to the device, the Notified Bodies and Fimea (Finnish Medicines Agency) should always be informed.

More information on Fimea’s homepage. 

AiVoni electrodes and AiVoni sensor on a table