I-CARE: the platform has obtained a CE Class I medical certification
ATTIVAZIONI SISTEMA ICARE
4 main courses and 30+ checkups, 70+ integrated medical devices that help keep health and well-being monitored
A team of bioengineers, medical consultants, medical device partners/suppliers and multidisciplinary outstanding researchers has largely contributed to the elaboration, evaluation and testing of the algorithms for building scores for each kind of check up measurement, according to recommendations based on range/parameters defined by medical device CE certification, on international guidelines or professionals’ own know how.
Certified in CE Class I
I-Care platform has obtained a CE Class I medical certification, which defines it as a tool for data storage and organization, though the platform collects measurements by means of specific CE Class II certified medical devices.
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The documents of I-CARE platform
Scientific opinion written by
Giacomo Biasucci, MD, Chief Paediatric & Neonatology Unit Maternal & Child Health Department Emilia-Romagna Regional Referral Clinical Centre for Inborn Errors of Metabolism and Eating Disorders in Childhood Guglielmo da Saliceto City Hospital Piacenza, Italy.
Declaration of conformity, obtained on 31/01/2018, to
DIRECTIVE 93/42 / EEC as implemented by Legislative Decree n.46 of 24/2/1997
and as amended by DIRECTIVE 2007/47 / EC
and the Essential Requirements expressed in Annex I of the DIRECTIVE (class I)