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392   References


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                [32] MEDDEV 2.7/1   Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under
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                [33] ISO 14155, Clinical Investigation of Medical Devices for Human Subjects—Good Clinical
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                [34] IEC TR 62366-2:2016, Medical Devices   Part 2: Guidance on the Application of Usability
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                [35] Code of Federal Regulations, Title 21, Part 820. ,www.accessdata.fda.gov/scripts/cdrh/cfdocs/
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