The CareLine platform is a CE-marked Class I medical device under Directive 93/42/EEC.
Certificates
Personal Health Data Hosting (AZNetwork)
CareLine Platform data are hosted by AZNetwork, a French cloud service provider certified for personal health data (HDS)
French Digital Health Agency certification
The CareLine Platform certification by ANS of compliance with interoperability and security common specifications and HAS common specifications for heart failure remote monitoring enable its coverage by the French Health Insurance.
ISO 13485 certification
CareLine Solutions has obtained its certificate of conformity to the ISO 13485:2016 standard for the design, development and marketing of digital solutions in the context of medical care.