Design control template
Design Review Form for medical device design controls
Use this editable Design Review to run phase-gated design controls, keep your Design History File (DHF) complete, and demonstrate that your device was developed under controlled requirements.
Trace requirements to validationLink user needs, design inputs, outputs, V&V and transfer.
Support DHF integrityDocument reviews, changes and design transfer in one controlled flow.
Ready for FDA/MDR auditsAlign with 21 CFR 820.30 and MDR Annex I expectations.
- Best for: DHF management, design planning, V&V evidence capture, design review and change control.
- Includes: editable sections for inputs, outputs, planning, reviews, transfer, changes and V&V records.
- Format: editable template available through the standard WooCommerce download flow.
Lexqara helps medical device manufacturers build robust design controls that satisfy both FDA QSR and EU MDR requirements. Explore the Resource Center or review our Design Control Services.
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.
Template preview
Template preview: Design Review
Review the key sections included in the Design Review template before downloading it. This preview shows the structure and content you will receive in the editable file.
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Project Name: XXXX
DHF Number: XXXX
Scope
This document is used to prepare, conduct, document, and approve the design review for the design and development of [Device Name].
Design Review Identification
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Review type
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Phase-gate review Design change review
Additional review
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Phase
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Phase 1 – Feasibility / Phase 2 – Design / Phase 3 – Development / Phase 4 – Industrialization / Phase 5 – Market Launch / N/A Select the appropriate phase
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Objective and scope of review
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State the purpose of the review and the boundaries of what is being assessed.
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Date of Design Review
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DD-Month-YYYY
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Design and Development Planning reference
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ZZZZ-PL-XXX rev.Y Enter the applicable D&D Plan reference and revision. Indicate N/A if in Phase 1.
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Traceability Matrix
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ZZZZ-TM-XXX rev.Y Enter the applicable Traceability Matrix reference and revision. Indicate N/A if in Phase 1.
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DHF number
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ZZZZ-DHF rev.Y Enter the applicable DHF number and revision.
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Participants
Indicate the individuals required (present or the back-up) and optional individuals present during the design review as referenced in the D&D Planning
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Name
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Position
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Required / Optional
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Presence
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Project Manager
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Required Optional
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Present
Back-up
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Required Optional
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Present
Back-up
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Required Optional
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Present
Back-up
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Required Optional
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Present
Back-up
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Required Optional
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Present
Back-up
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Required Optional
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Present
Back-up
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Independent Reviewer
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Required Optional
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Present
Back-up
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Previous Design Review Action Plan
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Action plan
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Date of closure
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Evidence
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Is the action complete and suitable?
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Consider the pending actions from the last design review
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XX-Mon-YYYY
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Indicate the document number and revision
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Yes
No: XXX indicate the conclusions and necessary actions.
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Design Review Meeting
Documentation review
The document list below represents the deliverables created or updated during the phase under assessment with their analysis during the design review meeting by the participants.
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Design Review Preparation
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Design Review Meeting
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Document Type
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Document number and revision
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Document title
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Required
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Approved
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Comments
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Suitability
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If “No”, Proposed Action Plan
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At least include the document type required in Section 5.2.6 of the design control procedure.
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Indicate all documents generated or updated during the phase.
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Indicate the corresponding document title
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Yes
No
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Yes
No
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Identify any gap, problem, risks identified with the justification if acceptable.
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Yes
No
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Indicate “-” if not applicable. Where applicable, describe the action plan agreed during the design review meeting and provide a justification if the issue does not prevent progression to the next phase.
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Additional Discussions During the Design Review Meeting
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Summary of the discussion
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Any issue to be mitigated?
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Proposed action plan
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Indicate the summary of important adhoc discussion with the conclusion
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Yes No
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If a problem must be addressed, indicate the action plan
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Yes No
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Design Change Assessment
Include the design change number and its description with the status of the change. The conclusion is based on the change status. If the design change is approved, the design review can be performed, if the change is not finalized or under reassessment, the design review is on hold, if the change is cancelled and the project is cancelled, then the design review needs to be cancelled.
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Design Change Number
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Change Description
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Status of the Change
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Conclusion
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Change approved
Change not finalized
Change under reassessment
Change is cancelled
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The design review can be performed
The design review is on hold
The design review is cancelled
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Conclusion and Decision from Design Review
Summary of assessment
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Assessment
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Conclusion
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The outputs of the current stage are complete, adequate, approved, compliant with applicable quality and regulatory requirements.
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Yes
No, but no significant concern raised
No, with significant concern raised
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#
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Summary of gaps identified:
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!
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Corresponding action plan:
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Action list
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Who?
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Due date
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1
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XXX List all gaps, problems, risks previously identified with a “No” in Suitability
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XXX Describe the corresponding action plan
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XX
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XX-Mon-YYYY
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2
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3
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Conclusion
Tick the box corresponding to the final decision and include below the associated justification.
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Go
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The design may proceed to the next stage.
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Go with action
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The design may proceed subject to completion of defined actions within agreed timelines.
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On hold
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Progression is suspended pending completion of required actions or resolution of identified issues.
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Stop
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The project or design stage is discontinued.
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Rationale for the decision
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Indicate a summary of the reason for the decision above (with especially the list of action items blocking the progression of the design review in the current phase)
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Approval
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Revision
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Date
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Change History
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Approval
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Name
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Position
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Date
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Signature
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Approval
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Name
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Position
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Date
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Signature
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Approval
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Name
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Position
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Date
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Signature
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Approval
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Name
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Position
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Date
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Signature
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Approval
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Name
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Position
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Date
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Signature
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