Technology Transfer Procedure | ISO 13485 | FDA QSR Compliant
- ISO 13485 and FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Technology Transfer ProcedureThe ISO 13485 Technology Transfer Procedure provides a phased approach for the transfer of product, equipment, tooling, and manufacturing processes from one location to another.
ISO 13485 Technology Transfer Procedure OverviewThe 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 Technology Transfer Procedure ComplianceThe Technology Transfer Procedure is FDA QSR and ISO 13485:2016 compliant.
To learn more about our Technology Transfer Procedure contact us at [email protected]
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