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SCHURTER Elevates Medical Device Standards with ISO 13485 Compliance

In Compliance Magazine -

In this recent Application Note, SCHURTER emphasizes the importance of compliance with the medical standard DIN EN ISO 13485 to ensure the safety and reliability of medical equipment, specifically as it relates to the development and integration of HMI solutions.

The post SCHURTER Elevates Medical Device Standards with ISO 13485 Compliance appeared first on In Compliance Magazine.

Maximum Isolation for Battery Management Systems

In Compliance Magazine -

Würth Elektronik expands its WE-BMS transformer series for battery management systems with versions for an operating voltage of 1500 VDC. The component design features enhanced isolation in line with IEC 62368-1 with triple-insulated wire, as well as galvanic isolation and a test voltage of 6400 VDC.

The post Maximum Isolation for Battery Management Systems appeared first on In Compliance Magazine.

How AI is Changing the Regulation of Medical Devices

In Compliance Magazine -

A recent paper published in the Journal of Law and the Biosciences maps out how the introduction of artificial intelligence (AI)-based medical devices may challenge current regulatory requirements, including the European Union’s Medical Device Regulation (MDR). The authors, who are affiliated with the Oxford Internet Institute in the United Kingdom, question the extent to which […]

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