Design transfer

The point where a design becomes a repeatable build. Drawings and tolerances become work instructions, tooling and inspection checks an operator can follow.

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When design transfer is the right step

After the design is verified and before the first production build. Design transfer turns the design history file into the records production builds from.

Production records from the design file
The drawings, specifications and test methods in the design history file become the device master record that production works from.
Tooling and fixtures
Moulds, jigs and fixtures specified and made, so that parts come out the same way every time.
Work instructions and pilot builds
Each assembly and inspection step written down, then tried in a pilot build before production relies on it.

What you bring, and what you get back

You bring

The design history file, or what exists of it
Released drawings, CAD and specifications
The bill of materials and the suppliers you use today
The risk file and the verification results
If a record is missing, the review at the start lists it.

You get back

A device master record that production can build from
Tooling and fixtures for production
Work instructions and inspection plans
A list of the processes that need validation, with the plans
Pilot build results: the problems found and how they were fixed
A transfer record that checks each design output as fit for production

A design that works is not yet a design that can be made

A prototype often works because the people who designed it also built it. They know which part to adjust and which step matters. Production needs that knowledge written into drawings, tolerances, work instructions and inspection criteria. ISO 13485 asks that design outputs are checked as suitable for manufacturing before they become production specifications.

How a design transfer runs

Step 1
Review the design outputs
We check drawings, specifications, the parts list and the risk file, and list any gaps.
Step 2
Define the process
The process flow, where each part is made, and which steps need validation.
Step 3
Make tooling and fixtures
Moulds, jigs and fixtures specified, made and checked against the drawings.
Step 4
Write instructions and checks
Work instructions, inspection plans and acceptance criteria for each step.
Step 5
Build a pilot
Units made from the new records, to test the records as much as the parts.
Step 6
Release to production
Outputs confirmed fit for production and released under change control.

Questions buyers ask

When should design transfer start?

Plan it during design, not after. Choices about materials, tolerances and joining methods decide how a part can be made. The transfer itself runs once the design is verified and stable.

What is the difference between the DHF and the DMR?

The design history file records how the design was developed and verified. The device master record holds what production needs: specifications, drawings, procedures, labelling and inspection criteria. Our article on design transfer explains more.

Which processes need validation?

Any process whose result cannot be fully checked afterwards, such as sealing or bonding. ISO 13485 asks that these processes are validated before they are used in production.

Can you transfer a design you did not develop?

Yes. The work starts with a review of the design file and a list of gaps. Gaps in verification or risk records are closed before transfer.

What comes after transfer?

Usually a pilot batch, built from the production records, to find problems before volume production.

A team meeting in front of a project plan on a screen

Design and production in one team

Nine disciplines work in one team, with the design office, labs and audited assembly lines together in Navi Mumbai. The engineers who designed a part are on hand when it is transferred.

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