Safety plays a significant role in medical technology. For hardly any other sector the reliability and safety of devices and machines is as essential as it is for the medical sector. Requirements concerning software for medical technology are particularly high as are result.
macios quality management system for the sector of medical devices is DIN EN ISO 13485:2012 certified. Furthermore, reliability and safety is achieved through IEC 62304-compliant development. Upon request we edit the software product development including a comprehensive support on the risk management for the licensing.
QMS and norms
DIN EN ISO 13485 | QMS – Requirements for regulatory purposes
DIN EN 62304 | Medical device software - Software lifecycle processes
EN 62366 | Application of usability engineering to medical devices
DIN EN ISO 14971 | Application of risk management to medical devices