Medical regulation

The "Aura" Solution is developped as a Class 2a Medical Device. In order to get the certification, we are working hard in the implementation of a "Startup Adapted" Quality Management System ensuring the global solution meets user expectations and safety requirements along each stage of development. All part of the global solution is developped with a high quality objective (hardware, embedded software, cloud software, documentations, ...). Here are the main norms wich drives our developpements :

• European reglementation :

  • Directive 93/42/CEE ;
  • ISO 13485 : Quality Management Systems ;
  • IEC 62304 : Software life cycle processes ;
  • IEC 14971 : Medical Device Risk Management ;
  • IEC 60601-1 (and 60601-x) : General Requirements for Safety ;
  • ...

• FDA reglementation :

  • 510(k) ;
  • ...