Clinical Investigation Procedure
The Clinical Investigation Procedure supports implementation of ISO 14155:2026. The Clinical Investigation procedure includes detailed information on all aspects of clinical investigations. The product includes a CIP protocol and report document, Investigators' brochure (IB) document, investigation site initiation and monitoring forms, informed consent document and guidance on CRF construction.
ISO 14155:2026 aligned
MDR EU 2017/745 aligned
ISO 13485:2016 aligned
Includes Multiple Forms
MS Word Format
Instant Download Digital File
The Clinical Investigation Procedure defines the process to conduct clinical investigations per MDR (EU) 2017/745 and ISO 14155:2026.
Clinical Investigation Procedure - Overview
The Clinical Investigation Procedure supports implementation of ISO 14155:2026. The Clinical Investigation procedure includes detailed information on all aspects of clinical investigations. The product includes a CIP protocol and report document, Investigators' brochure (IB) document, investigation site initiation and monitoring forms, informed consent document and guidance on CRF construction.
Clinical Investigation Procedure - Compliance
The Clinical Investigation Procedure is Medical Device Regulation (EU) 2017/745, ISO 14155:2026 and ISO 13485:2016 aligned.
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