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Move a device from design into validated, repeatable production. A working DMR, IQ/OQ/PQ, and production-readiness workbook plus validation-protocol and transfer-plan templates - the way MEDEVEX takes products through design transfer and launch.
A design-transfer workbook (Excel): a DMR contents index (21 CFR 820.181), an IQ/OQ/PQ validation tracker, a cross-functional Production Readiness gate, and a readiness dashboard.
A Validation Protocol (IQ/OQ/PQ) template (Word).
A Design Transfer & Production Readiness Plan template (Word).
A start-here guide with license terms.
Manufacturing and quality engineers, operations leads, and startup founders moving a medical device or IVD from development into production who need a clean design transfer and validated, inspection-ready processes.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Want the governing procedure too? The Design Transfer & Process Validation System Pack adds the SOP that governs these transfer and validation tools.
Because this is an instant digital download, all sales are final and non-refundable. If a file won’t download or appears corrupted, email aaron.vant@medevexconsulting.com and we’ll make it right. Single-organization license; not for resale or redistribution.Move a device from design into validated, repeatable production. A working DMR, IQ/OQ/PQ, and production-readiness workbook plus validation-protocol and transfer-plan templates - the way MEDEVEX takes products through design transfer and launch.
A design-transfer workbook (Excel): a DMR contents index (21 CFR 820.181), an IQ/OQ/PQ validation tracker, a cross-functional Production Readiness gate, and a readiness dashboard.
A Validation Protocol (IQ/OQ/PQ) template (Word).
A Design Transfer & Production Readiness Plan template (Word).
A start-here guide with license terms.
Manufacturing and quality engineers, operations leads, and startup founders moving a medical device or IVD from development into production who need a clean design transfer and validated, inspection-ready processes.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Want the governing procedure too? The Design Transfer & Process Validation System Pack adds the SOP that governs these transfer and validation tools.
Because this is an instant digital download, all sales are final and non-refundable. If a file won’t download or appears corrupted, email aaron.vant@medevexconsulting.com and we’ll make it right. Single-organization license; not for resale or redistribution.