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.
ISO 13485:2016 and FDA QMSR aligned
Includes Related Forms
MS Word Format
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The ISO 13485:2016 Technology Transfer Procedure provides a phased approach for the transfer of product, equipment, tooling, and manufacturing processes from one location to another.
ISO 13485:2016 Technology Transfer Procedure Overview
The Technology Transfer Procedure includes detailed guidance on the development of a medical device transfer plan moving a product from one facility to another. The technology transfer planning includes quality planning, supply chain planning, documentation planning, master validation planning, production planning, facilities planning, sterilization planning, and training planning. The Technology Transfer Procedure is ideal for use in product acquisitions and factory relocation efforts. The phase /gate approach and accompanying forms include in depth action items, milestones and specified requirements that need to be met before continuing on to next phase.
ISO 13485:2016 Technology Transfer Procedure Compliance
The Technology Transfer Procedure is FDA QMSR and ISO 13485:2016 aligned.
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Regulatory framework
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.
