IDA wants to make visible the link to the United Nations 17 Sustainable Development Goals (SDG). This event covers, among other things, the above development goals. Read more about the UN's 17 Sustainable Development Goals (SDG)
Usability Engineering and Regulatory Requirements for Medical Devices
When it comes to medical equipment, proper operation and usage can be a matter of life and death
Therefore, developing medical devices requires ensuring – and documenting – that the equipment is safe to use. It is thus a regulatory requirement to follow a ‘Usability Engineering Process’ during the development of medical devices and pharma products.
The requirements and expectations for this process are defined in IEC 62366-1:2015/Amd 1:2020 and the – FDA’s (US Food and Drug Administration) guidance Applying Human Factors and Usability Engineering to Medical Devices.
IDA wants to make visible the link to the United Nations 17 Sustainable Development Goals (SDG). This event covers, among other things, the above development goals. Read more about the UN's 17 Sustainable Development Goals (SDG)
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