• Sven Jungmann

Clinical evaluation

Clinical evaluation is a process undertaken by the manufacturer with both initial and ongoing/routine actions to substantiate the safety, effectiveness, and performance of their product or device. Methods for assessment must be scientifically based and include:

  • Collection of initial clinical data and clinical evidence

  • Adverse event reports

  • Results from further clinical investigations

  • Published literature/reports on the device

The end result of this evaluation process is a report proving compliance for regulatory purposes (generally this means substantiating general safety and that the benefits outweigh any “acceptable” risks).

Source: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n56.pdf

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