• Sven Jungmann

Clinical evidence

Clinical evidence is a critical component of technical documentation for a product or device. It is generated by the clinical evaluation of clinical data and is required to demonstrate compliance or conformity to essential safety principles. Additionally, this evidence supports the marketing and the labelling of a device (proof of claims).

Innovators should keep in mind that clinical evaluation and evidence is an ongoing process, which requires review and update routinely.

Source: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n55.pdf

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