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The procedure and the validation tools, together. A tailorable Design Transfer & Process Validation Procedure (SOP) paired with the Design Transfer Toolkit — take a design into validated, repeatable production and pass inspection.
A tailorable Design Transfer & Process Validation Procedure (SOP, Word) governing DMR, IQ/OQ/PQ, and production release.
The Design Transfer Toolkit: a DMR contents index, an IQ/OQ/PQ validation tracker, a cross-functional Production Readiness gate, and a readiness dashboard.
Validation Protocol (IQ/OQ/PQ) and Design Transfer & Production Readiness Plan templates.
A tailoring guide showing what to edit and how the SOP links to the tools.
Single-organization license; edit and co-brand for internal use.
Manufacturing and quality engineers and operations leads moving a medical device or IVD from development into validated production.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
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.The procedure and the validation tools, together. A tailorable Design Transfer & Process Validation Procedure (SOP) paired with the Design Transfer Toolkit — take a design into validated, repeatable production and pass inspection.
A tailorable Design Transfer & Process Validation Procedure (SOP, Word) governing DMR, IQ/OQ/PQ, and production release.
The Design Transfer Toolkit: a DMR contents index, an IQ/OQ/PQ validation tracker, a cross-functional Production Readiness gate, and a readiness dashboard.
Validation Protocol (IQ/OQ/PQ) and Design Transfer & Production Readiness Plan templates.
A tailoring guide showing what to edit and how the SOP links to the tools.
Single-organization license; edit and co-brand for internal use.
Manufacturing and quality engineers and operations leads moving a medical device or IVD from development into validated production.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
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.