Technology Transfer Procedure

The Technology Transfer Procedure provides a concise and logical phased approach for the transfer of medical device products, equipment, and manufacturing processes from one manufacturing facility to another.

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Supplied as one editable Microsoft Word document and a PDF flow chart in a digital download.

Transfer planning

It guides development of a plan for moving a product between facilities. The plan covers quality, supply chain, documentation, master validation, production, facilities, sterilization and training. It is intended for product acquisitions and facility relocations. The phase-gate approach and accompanying forms identify action items, milestones and requirements to complete before moving to the next phase.

A phased transfer plan

Technology transfer begins with project assessment and planning. The project team reviews design controls, process controls, quality requirements, suppliers, equipment and documentation before executing the transfer. The source procedure separates assessment, plan development, execution and completion activities so responsibilities and readiness can be reviewed at each stage.

Execution records

The transfer plan addresses training, equipment and production preparation, communication between sending and receiving teams, and the records used to demonstrate completion. It is suited to moving an existing product or process between sites or to a contract manufacturer.

Standards and frameworks addressed: ISO 13485:2016 and FDA QMSR.

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

Related handoff procedure

For the distinct handoff from design and development into manufacturing, see the separately sold Design Transfer Procedure. This Technology Transfer Procedure addresses moving an existing product, equipment or manufacturing process between facilities.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Technology Transfer Between Manufacturing Facilities for workflow guidance, a checklist and common mistakes.