Certified medical device

European legislation imposes strict rules for all certified medical devices.

Manufacturers must demonstrate that their technology has been medically proven and undergo audits to verify its proper functioning.

Discover below the steps necessary for such a validation:




First, it is necessary to recruit candidates who agree to take part in Sunrise's clinical validation. It is the medical examiner who offers his patients the opportunity to participate. Sunrise's strength lies in the large number of people who took part in this validation: 400 people.




Every night requires the installation of many sensors on the sleeper. A specialized technician takes care of this procedure, which takes about 45 minutes.




The results of the two measurement methods (polysomnography and Sunrise) are then compared: it is verified that the results obtained by each of the methods match.




The results of the study conclude that there is a level of agreement of more than 95% between the two technologies for the detection of obstructive sleep apnea in adults. This is a first at this level of performance. A revolution in sleep medicine.




The authorities, through a notified body, then carry out an audit at the company's site.




People who agree to take part in the study then go to the sleep laboratory for a night of observation.




Each person then spends the night in hospital, equipped with the test equipment used in the sleep laboratory (polysomnography) and the Sunrise sensor, which is being validated.




A sleep expert reviews and analyses the polysomnography results in 30-second increments.




Once this validation has been completed, the Sunrise team contacts the health authorities to notify the European Union market launch.




Once this audit and the various verifications have been successfully completed, Sunrise receives the certificate of conformity which gives access to the CE-marking.




First, it is necessary to recruit candidates who agree to take part in Sunrise's clinical validation. It is the medical examiner who offers his patients the opportunity to participate. Sunrise's strength lies in the large number of people who took part in this validation: 400 people.




People who agree to take part in the study then go to the sleep laboratory for a night of observation.




Every night requires the installation of many sensors on the sleeper. A specialized technician takes care of this procedure, which takes about 45 minutes.




Each person then spends the night in hospital, equipped with the test equipment used in the sleep laboratory (polysomnography) and the Sunrise sensor, which is being validated.




The results of the two measurement methods (polysomnography and Sunrise) are then compared: it is verified that the results obtained by each of the methods match.




A sleep expert reviews and analyses the polysomnography results in 30-second increments.




The results of the study conclude that there is a level of agreement of more than 95% between the two technologies for the detection of obstructive sleep apnea in adults. This is a first at this level of performance. A revolution in sleep medicine.




Once this validation has been completed, the Sunrise team contacts the health authorities to notify the European Union market launch.




The authorities, through a notified body, then carry out an audit at the company's site.




Once this audit and the various verifications have been successfully completed, Sunrise receives the certificate of conformity which gives access to the CE-marking.






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