From now on Emma bears the CE mark as a Class I non-invasive active medical device. The Medicine Men team has worked hard to comply to all the requirements in order to receive the certification.
Emma is now officially registered as a Class I non-invasive active medical device. This means Emma is an information-exchanging platform that monitors medication intake and medication adherence without penetrating inside the body.
The Medicine Men Team spent months working on the CE documentation to ensure that Emma complies to the European directives in every way. Privacy, customer service and the technical quality of the system have been taken into account. Everything also needed to be in order behind the scenes. Medicine Men has brought the internal communication and documentation to such a level that the safety of the users is constantly guaranteed.
After a successful visit of the Dutch Health Inspection (IGZ) Emma can officially bear the CE certificate.