Checklist: Design Transfer to Manufacturing

This is an extra resource to go along with the original article:

Best Practices for an Effective Medical Device Design Transfer Process

As part of the design transfer process, you must be able to properly articulate your product
design into production specifications and capabilities that meet product requirements. Use this
checklist to confirm the development and approval of the following design transfer activities,
which will then be used to compile your Device Master Record:

Manufacturing process flow and work-cell set-up

Production and environmental controls

Manufacturing procedures or instructions

Manufacturing jigs, fixtures, molds, aids

Training materials

Test specifications

Inspection specifications and procedures

Bill of materials (BOM)

Packaging procedures

Labeling procedures

Applicable qualifications

Customer-specified production specifications (i.e. CoC, RoHS, sterilization records

specifications)

Risk Management Report

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