Description:

This document supports a controlled, documented design review to confirm phase deliverables are complete, suitable, and ready for the next decision.
• Identify Review type (phase-gate, design change, or additional review) and the project Phase.
• Record Project Name, DHF Number, and the Date of Design Review for traceability.
• Link key references: Design and Development Planning, Traceability Matrix, and applicable DHF revision.
• Define Participants (required/optional) and include an Independent Reviewer where applicable.
• Review the previous Action plan with closure evidence and suitability conclusion.
• Assess phase deliverables for Approved status and Suitability, with a proposed action plan when “No”.
• Capture the final decision (Go / Go with action / On hold / Stop) with rationale and an action list.

Your needs:

• medical device design review aligned with ISO 13485 requirements
• medical device design review for MDR decision-making
• Reduce rework by locking clear actions, owners, and evidence before moving phases.

Use this form before moving to the next development phase, after compiling updated deliverables and identifying any open risks, gaps, or pending changes to be reviewed and approved.

It helps standardize expectations for review readiness. Suitability means the deliverable is adequate for the phase and can support progression, and an Action plan assigns ownership and deadlines so gaps are closed with evidence.
• Confirm review scope, boundaries, and references are complete.
• Verify attendee roles, presence, and independence as required.
• Evaluate deliverables, approval status, and documented comments.
• Record additional discussions, issues to mitigate, and actions.
• Conclude with a clear go/no-go decision and blocking actions.

Within Lexqara, we help align DHF evidence, and run pragmatic design control check-ins so decisions are defensible during audits and inspections. See our Resource Center and our Design Control Support for Start-up Companies, and benchmark expectations via FDA Design Controls guidance. Request a short design review readiness check.

Consistent use of this template improves phase-gate discipline, keeps design changes transparent, and strengthens traceability from planning to action closure.