CEN/TC 258/WG 2 - Clinical investigation plans
To provide a framework for the organisation and content of clinical investigation plans which would include requirements specifically intended to ensure rigour and scientific value. To draft relevant documents dealing with the review of the scientific literature to, inter alia, support clinical investigation plans and assist the analysis of clinical data.
Clinical investigation plans
To provide a framework for the organisation and content of clinical investigation plans which would include requirements specifically intended to ensure rigour and scientific value. To draft relevant documents dealing with the review of the scientific literature to, inter alia, support clinical investigation plans and assist the analysis of clinical data.
General Information
1 Scope
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day