Happitech has received CE Certification for its HR, HRV and AF Detection SDK for iOS and Android.
The Happitech Heart Rhythm SDK is classified as a Class 2a device on 24th of March 2020.
The approval and audit was carried out by KIWA providing Happitech with both EC certificate that acknowledges full quality assurance system according to Medical Devices Directive 93/42/EEC Annex II Section 3. In addition to receiving Medical Quality Management Systems ISO 13485:2016 for the “Design, Development, Manufacturing and Cardiovascular Monitoring Application”.
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