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This Clinical Investigation Report Template has been created according to Regulation 2017/745, MDCG 2021-6 Rev.1, 21 CFR Part 812, Ordinance on Clinical Trials with Medical Devices (ClinO-MD) SR 810.306 and ISO 14155.
It is applicable to clinical investigations with medical devices conducted in European Union, Switzerland and the United States. Specific content for each region is marked.
It contains predefined sections and provides recommended guidance for filling in content.
19 pages
It is applicable to clinical investigations with medical devices conducted in European Union, Switzerland and the United States. Specific content for each region is marked.
It contains predefined sections and provides recommended guidance for filling in content.
19 pages