What We Do?

CDAQI research provide a Comprehensive and End to End Clinical Trial Management Services for Medical Devices Industry, which included Clinical Investigation of medical device.
Clinical Investigation Report is prepared as per EU Medical Device Regulation 2017/745 of Annex XV requirements and ISO 14155:2020- Clinical investigation of medical devices for human subjects — Good clinical practice.
Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles.
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Clinical Investigation Report

Structure of ISO 14155:2020 Annexes
- Annex A Clinical investigation plan (CIP) (normative)
- Annex B Investigator’s brochure (IB) (normative)
- Annex C Case report form (CRFs) (informative)
- Annex D Clinical investigation report (normative)
- Annex E Essential clinical investigation documents (informative)
- Annex F Adverse event categorization (informative)
- Annex G EC responsibilities (informative)
- Annex H Application of ISO 14971 to clinical investigations (informative)
- Annex I Clinical development stages(informative)
- Annex J Clinical investigation audits (informative)
