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IEC 80001-1 IT Networks incorporating Medical Devices

Health care providers face a multiplicity of new responsibilities which require the provision of highly trained expert staff and the enhancement of the existing quality management and risk management system.

The increasing integration of medical devices and medical systems into IT-networks and the ongoing application of international standards for Risk Management (ISO 14971) or System Integration (IEC 80001-1) challange health care providers in hospitals, group practices, and medical supply centers with major changes.

The philosophy of system responsibility has fundamentally changed. While in the past the medical device manufacturer was respnsible for the interoperability of the devices, in the future the responsible organisation will be responsible and liable for a functional communication between medical devices and medical systems. 

To support the objective of secure IT-sytems, it is PROSYSTEM's goal to enhance the dialogue between stakeholders and bring together healthcare providers and medical device manufacturers.

PROSYSTEM provides medical device manufacturers and healthcare providers a platform  and koordinates the analysis and implementation of medical IT-networks. 

 

 

  

 

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