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DescriptionDetails & specsAttachments
This procedure has been created in accordance with ISO 14155, Regulation (EU) 2017/745, FDA 21 CFR 812, the Human Research Act (HRA) and the ordinance on Clinical Trials with Medical Devices (ClinO-MD).
It is applicable to clinical investigations conducted in European Union, Switzerland and the United States. Specific content for each region is marked.
It can be used by sponsors of clinical investigation conducted with medical devices.
It contains predefined sections and provides recommended guidance for filling in content.
42 pages
It is applicable to clinical investigations conducted in European Union, Switzerland and the United States. Specific content for each region is marked.
It can be used by sponsors of clinical investigation conducted with medical devices.
It contains predefined sections and provides recommended guidance for filling in content.
42 pages