Medical Device Investigator Brochure
Prepare investigator information for a medical device clinical study with this standalone editable Investigator Brochure. It prompts device purpose and design, preclinical and clinical information, known risks and anticipated benefits. The broader Clinical Investigation Procedure package is sold separately.
Supplied as one editable Microsoft Word document in a digital download.
Standalone investigator information and scope
Related documentation
A.P. Lyon also offers a broader Clinical Investigation Procedure package containing an Investigator's Brochure document, clinical investigation plan and report documents, site initiation and monitoring forms, and an informed-consent document.
This listing is for the standalone Investigator Brochure. For the broader study workflow and its included plan, report, brochure, site forms and informed-consent material, see the Clinical Investigation Procedure. That procedure is also one of the five products in the Clinical Evaluation Procedure Bundle.
The supplied document prompts a sponsor to explain the investigational device, its intended purpose and design, preclinical and clinical information, known risks and anticipated benefits. It organizes the facts an investigator needs to understand the device and conduct the planned study. The form should be completed with device-specific evidence and reviewed alongside the clinical investigation plan; this single product does not include the broader clinical-investigation procedure package.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Clinical Investigation Documents: Plan, Investigator Brochure and Report for workflow guidance, a checklist and common mistakes.
