Design Transfer Form

Design control template

Design Transfer Form for medical device design controls

Use this editable Design Transfer 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.

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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:

Use this design transfer meeting minutes template to confirm your final design is fully translated into production-ready specifications, controls, and support activities.
• Record Project Name, DHF Number, Date of Design Transfer, and Phase 5 readiness context.
• Link governing references: Design and Development Planning, Traceability Matrix, DHF, and MDF (DMR) numbers.
• Confirm required roles (incl. PRRC, industrialization quality, MDR regulatory specialist, and Independent Reviewer) are present.
• Review closure of the previous design review action plan with evidence.
• Verify MDF/DMR completeness: UDI specifications, labeling/IFU, product/purchasing specs, and the risk management file.
• Assess production controls: incoming/in-process/final inspection, manufacturing, packaging, storage, handling, distribution, installation, servicing.
• Confirm process validation readiness (QI/QO/QP), software control in production, calibration, environmental control, and training readiness.

Your needs:

• medical device design transfer aligned with ISO 13485 requirements
• medical device design transfer for MDR decision-making
• Reduce launch delays by proving the DMR and production controls are truly ready.

Use this form at market launch readiness to ensure the approved design outputs can be consistently manufactured, inspected, released, installed, and serviced as intended.

It defines what “ready” means: the DMR must be complete and suitable, and process/inspection controls must reliably meet product requirements. QI/QO/QP capture installation, operational, and performance qualification evidence for validated processes.
• Confirm DMR/MDF sections are complete and suitable with actions if gaps exist.
• Ensure supplier control status and quality agreements are in place as needed.
• Verify process controls, validation evidence, and monitoring of validated processes.
• Confirm software used in production/control is validated and risk-appropriate.
• Confirm calibration, environment controls, and training records before transfer.

Within Lexqara, we help align design transfer readiness with QMS implementation, audit readiness, supplier control, and inspection support—without overpromising outcomes. Visit our Resource Center and our Design Control Support for Start-up Companies, and align your approach with EU MDR (Regulation (EU) 2017/745). Request a short design transfer readiness check.

A disciplined design transfer reduces downstream NCRs and supports stable scale-up by keeping production evidence and design intent fully traceable.

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Template preview: Design Transfer

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Project Name: XXXX

DHF Number: XXXX

Scope

This document is used to prepare, conduct, document, and approve the design transfer for the design and development of [Device Name].

Design transfer Identification

Review type	Design Transfer
Phase	Phase 5 – Market Launch
Objective and scope of review	The objective of design transfer is to ensure that the final device design is correctly translated into production specifications, manufacturing processes, quality controls, and related support activities so that the device can be consistently manufactured, inspected, released, installed, and serviced in accordance with the approved design requirements.
Date of Design Transfer	DD-Month-YYYY
Design and Development Planning reference	ZZZZ-PL-XXX rev.Y Enter the applicable D&D Plan reference and revision.
Traceability Matrix	ZZZZ-TM-XXX rev.Y Enter the applicable Traceability Matrix reference and revision.
DHF number	ZZZZ-DHF rev.Y Enter the applicable DHF number and revision.
MDF (DMR) number	ZZZZ-MDF rev.Y Enter the applicable MDF number and revision.

Participants

Indicate the individuals required (present or the back-up) and optional individuals present during the design transfer as referenced in the D&D Planning

Position	Required / Optional	Presence
Project Management	Required Optional	Present Back-up
PRRC	Required Optional	Present Back-up
Specialist in market need	Required Optional	Present Back-up
Design Manager	Required Optional	Present Back-up
Regulatory specialist under MDR	Required Optional	Present Back-up
Quality Engineer (industrialization)	Required Optional	Present Back-up
Quality management system specialist	Required Optional	Present Back-up
Independent Reviewer	Required Optional	Present Back-up

Previous Design Review Action Plan

Action plan	Date of closure	Evidence	Is the action complete and suitable?
Consider the pending actions from the last design review	XX-Mon-YYYY	Indicate the document number and revision	Yes No: XXX indicate the conclusions and necessary actions.

Design Transfer Meeting

Medical Device File (Device Master Record) Review

The Medical Device File (MDF) or Device Master Record (DMR) has been reviewed to ensure that design outputs are suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements. The conclusion of this review is documented in the following table:

Verification activities	Is the MDF suitable^[1]?	If No, Proposed Action Plan
General description of the medical device	Yes No	Indicate “-” if not applicable. Where applicable, describe the action plan agreed during the design transfer meeting
Intended use/purpose	Yes No
Labelling, including any instructions for use	Yes No
UDI specifications	Yes No
Product specifications	Yes No
Purchasing specifications	Yes No
Risk management file	Yes No
Specifications and procedures for incoming inspections	Yes No
Specifications and procedures for in-process inspections	Yes No
Specification and procedure for final control/product release	Yes No
Specifications and procedures for manufacturing	Yes No
Specifications and procedures for packaging	Yes No
Specifications and procedures for storage	Yes No
Specifications and procedures for handling	Yes No
Specifications and procedures for distribution	Yes No
Procedures for measuring and monitoring	Yes No
Specifications and procedures for installation	Yes No
Specifications and procedures for servicing	Yes No

Supplier Control

The suppliers involved in the supply of materials, components, subassemblies, outsourced processes, or services affecting product quality have been reviewed to ensure that they are approved, adequately controlled, and ready to support routine production, installation or servicing. This review confirms, as applicable, that supplier requirements are defined, quality or technical agreements are established where needed, and no identified supplier-related issue prevents transfer to production. The conclusion of this review is documented in the following table:

Supplier Name	Item/Services Provided	Status of the Supplier/Sub-contractor			If Not Approved, Proposed Action Plan
Supplier Name	Item/Services Provided	Supplier category	Quality Agreement	Approved Supplier	If Not Approved, Proposed Action Plan
XXXX	XXXX	Critical / Major / Minor	Yes No	Yes No

Process Control

The manufacturing processes have been reviewed to ensure that the methods used to control these processes are defined and suitable to consistently manufacture the device in accordance with the approved product requirements. This review includes, as applicable, inspection activities, process validation status, and monitoring of validated processes. The conclusion of this review is documented in the following table:

Manufacturing Process	Control of Process	Is the process control suitable?
XXXX Equipment ID: XXXX	100%	QI QO QP Monitoring of validated process Evidence:	Yes No If no, action plan: XXX
XXXX Equipment ID: XXXX	100%	QI QO QP Monitoring of validated process Evidence:	Yes No If no, action plan: XXX
XXXX Equipment ID: XXXX	100%	QI QO QP Monitoring of validated process Evidence:	Yes No If no, action plan: XXX
XXXX Equipment ID: XXXX	100%	QI QO QP Monitoring of validated process Evidence:	Yes No If no, action plan: XXX
XXXX Equipment ID: XXXX	100%	QI QO QP Monitoring of validated process Evidence:	Yes No If no, action plan: XXX
XXXX Equipment ID: XXXX	100%	QI QO QP Monitoring of validated process Evidence:	Yes No If no, action plan: XXX
XXXX Equipment ID: XXXX	100%	QI QO QP Monitoring of validated process Evidence:	Yes No If no, action plan: XXX

Manufacturing Process

Control of Process

Is the process control suitable?

Inspection

Validation

XXXX

Equipment ID: XXXX

100%

QI QO QP

Monitoring of validated process

Evidence:

Yes No

If no, action plan:

XXX

XXXX

Equipment ID: XXXX

100%

QI QO QP

Monitoring of validated process

Evidence:

Yes No

If no, action plan:

XXX

XXXX

Equipment ID: XXXX

100%

QI QO QP

Monitoring of validated process

Evidence:

Yes No

If no, action plan:

XXX

XXXX

Equipment ID: XXXX

100%

QI QO QP

Monitoring of validated process

Evidence:

Yes No

If no, action plan:

XXX

XXXX

Equipment ID: XXXX

100%

QI QO QP

Monitoring of validated process

Evidence:

Yes No

If no, action plan:

XXX

XXXX

Equipment ID: XXXX

100%

QI QO QP

Monitoring of validated process

Evidence:

Yes No

If no, action plan:

XXX

XXXX

Equipment ID: XXXX

100%

QI QO QP

Monitoring of validated process

Evidence:

Yes No

If no, action plan:

XXX

Software Control in Production

The software used in production and production control has been reviewed to ensure that it is suitable for its intended use and adequately controlled to support product conformity. This review includes, as applicable, software risk level, inspection activities, and software validation status. The conclusion of this review is documented in the following table:

Software in Production/Control	Control of Software			Is the software control suitable?
Software in Production/Control	Inspection	Risk Level	Software validation	Is the software control suitable?
XXXX	100%	XXX	QI QO QP Evidence:	Yes No If no, action plan: XXX
XXXX	100%	XXX	QI QO QP Evidence:	Yes No If no, action plan: XXX
XXXX	100%	XXX	QI QO QP Evidence:	Yes No If no, action plan: XXX
XXXX	100%	XXX	QI QO QP Evidence:	Yes No If no, action plan: XXX
XXXX	100%	XXX	QI QO QP Evidence:	Yes No If no, action plan: XXX
XXXX	100%	XXX	QI QO QP Evidence:	Yes No If no, action plan: XXX
XXXX	100%	XXX	QI QO QP Evidence:	Yes No If no, action plan: XXX

Control of Measuring Equipment

The measuring equipment used during manufacturing and control activities has been reviewed to ensure that it is identified, suitable for its intended use, and subject to appropriate calibration control where required. This review confirms whether the measuring equipment used to verify product conformity is adequately calibrated and controlled. The conclusion of this review is documented in the following table:

Manufacturing process	Calibration Control		If No, Proposed Action Plan
Manufacturing process	Measuring equipment used	Is the measuring equipment calibrated?	If No, Proposed Action Plan
XXXX	XXXX	Yes No	If no, action plan: XXX
XXXX	XXXX	Yes No	If no, action plan: XXX
XXXX	XXXX	Yes No	If no, action plan: XXX
XXXX	XXXX	Yes No	If no, action plan: XXX
XXXX	XXXX	Yes No	If no, action plan: XXX
XXXX	XXXX	Yes No	If no, action plan: XXX
XXXX	XXXX	Yes No	If no, action plan: XXX
XXXX	XXXX	Yes No	If no, action plan: XXX

Environmental Control in Production

The environmental conditions applicable to production have been reviewed to ensure that the relevant environmental parameters are identified, monitored, and adequately controlled where necessary to maintain product conformity. This review confirms whether the required environmental controls are implemented and suitable for the manufacturing processes concerned. The conclusion of this review is documented in the following table:

Manufacturing process	Environmental Control		If No, Proposed Action Plan
Manufacturing process	Environmental Controlled Parameter	Monitoring Verified and Suitable?	If No, Proposed Action Plan
XXXX		Yes No	If no, action plan: XXX
XXXX		Yes No	If no, action plan: XXX
XXXX		Yes No	If no, action plan: XXX
XXXX		Yes No	If no, action plan: XXX
XXXX		Yes No	If no, action plan: XXX
XXXX		Yes No	If no, action plan: XXX
XXXX		Yes No	If no, action plan: XXX
XXXX		Yes No	If no, action plan: XXX

Training Readiness

The training status of personnel involved in production, inspection, installation, and servicing activities has been reviewed to ensure that the relevant employees are adequately trained and qualified for the activities they perform. This review confirms whether the training records are complete and whether any additional training is required before transfer to routine operations. The conclusion of this review is documented in the following table:

Employees	Training verification for activities in:	Is the training folder complete?
XXXX	Yes No N/A	Yes No N/A	Yes No N/A	Yes No If no, training plan: XXX
XXXX	Yes No N/A	Yes No N/A	Yes No N/A	Yes No If no, training plan: XXX
XXXX	Yes No N/A	Yes No N/A	Yes No N/A	Yes No If no, training plan: XXX

Employees

Training verification for activities in:

Is the training folder complete?

Production

Inspections

Installation / Servicing

XXXX

Yes

N/A

Yes

N/A

Yes

N/A

Yes No

If no, training plan:

XXX

XXXX

Yes

N/A

Yes

N/A

Yes

N/A

Yes No

If no, training plan:

XXX

XXXX

Yes

N/A

Yes

N/A

Yes

N/A

Yes No

If no, training plan:

XXX

Additional Discussions During the Design transfer Meeting

Any additional topics discussed during the design transfer meeting that are not otherwise captured in this form shall be documented in this section. This includes relevant issues, concerns, clarifications, or decisions that may affect design transfer readiness or require follow-up actions. The conclusion of these discussions is documented in the following table:

Summary of the discussion	Any issue to be mitigated?	Proposed action plan
Indicate the summary of important adhoc discussion with the conclusion	Yes No	If a problem must be addressed, indicate the action plan
	Yes No

Conclusion and Decision from Design transfer

Summary of assessment

The overall results of the design transfer review have been consolidated to determine whether the Device Master Record (DMR) is complete and suitable to ensure that production capability can meet product requirements. Any gaps, problems, or risks identified during the design transfer review, together with the corresponding action plans, are summarized in the following table:

Assessment			Conclusion
Is the DMR complete and suitable to ensure that production capability meets product requirements?			Yes No, but no significant concern raised No, with significant concern raised
#	Summary of gaps identified:	!^[2]	Corresponding action plan:
#	Summary of gaps identified:	!^[2]	Action list	Who?	Due date
1	XXX List all gaps, problems, risks		XXX Describe the corresponding action plan	XX	XX-Mon-YYYY
2
3

Conclusion

Based on the assessments performed during the design transfer review, a final decision shall be made regarding the readiness of the design for transfer to production. This decision shall take into account the completeness of the DMR, the suitability of production controls, and the significance of any remaining gaps or pending actions. The final decision and its justification are documented below:

Tick the box corresponding to the final decision and include below the associated justification.

Go	The design is complete and the device is transferred in production
Go with action	The design can be transferred to production despite non-significant pending actions that shall be completed within the agreed timelines
On hold	Progression is suspended pending completion of required actions or resolution of identified issues
Stop	The design transfer is discontinued.
Rationale for the decision
Indicate a summary of the reason for the decision above (with especially the list of action items blocking the progression of the design transfer in the current phase)

Approval

Revision	Date	Change History

Approval
Name
Position
Date
Signature

Approval
Name
Position
Date
Signature

Approval
Name
Position
Date
Signature

Approval
Name
Position
Date
Signature

Approval
Name
Position
Date
Signature

Suitability is verified through the confirmation that documents are complete, adequate and approved. ↑
When an action is identified with “!” (critical), the design transfer cannot not complete and finalized. ↑

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Design Transfer Form