Medical Device IRB Protocols
Fast-track your clinical validation or feasibility study submission. Upload existing protocol drafts, use device-specific templates, and export IRB packets ready for submission.
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Create your first clinical validation or feasibility study protocol with device-specific IRB templates, or import an existing draft.
Device Trial Workflow Features
Import Existing Protocol
Already have an investigational plan or clinical evaluation report? Upload your PDF, DOCX, or TXT file and ClearPath will structure it into IRB-ready format.
Device-Specific Templates
Choose your study design (feasibility, pivotal, post-market) and get pre-filled templates with appropriate endpoints, risk classifications, and regulatory sections.
IRB Reviewer Preview
See your protocol through IRB eyes. Get flagged sections (adverse event reporting, device accountability, monitoring plans) with suggested revisions before submission.
Submission-Ready Export
Export complete IRB packages with investigator's brochure sections, informed consent, and device accountability forms. DOCX and PDF formats included.
Document Checklist
Track required attachments: informed consent documents, investigator agreements, device specifications, and monitoring plans. Upload before final submission.
FDA Pre-Sub Integration
Flag device studies for FDA Pre-Submission meetings. ClearPath saves protocol metadata to streamline your regulatory pathway documentation.