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 :
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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 ;
- ...
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FDA reglementation :
- 510(k) ;
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