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Design controls that trace themselves. A working requirements-traceability workbook plus design-plan and review templates - built the way MEDEVEX takes devices from customer needs to launch with a Design History File auditors can follow.
A Design Controls workbook (Excel): a Requirements Traceability Matrix (user need → input → output → verification → validation) that auto-flags traceability gaps, a V&V test matrix with sample-size rationale, a stage-gate/design-review tracker, a DHF index, and a coverage dashboard.
A Design & Development Plan template (Word).
A Design Review Report template (Word).
A start-here guide with license terms.
Design and quality engineers, R&D leads, and startup founders building medical devices or IVDs who need airtight design controls and traceability (ISO 13485 Cl. 7.3 / 21 CFR 820.30) without building the spreadsheets from scratch.
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 Controls System Pack pairs this toolkit with a tailorable Design & Development Control Procedure (SOP) so your design controls are audit-ready, not just organized.
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.Design controls that trace themselves. A working requirements-traceability workbook plus design-plan and review templates - built the way MEDEVEX takes devices from customer needs to launch with a Design History File auditors can follow.
A Design Controls workbook (Excel): a Requirements Traceability Matrix (user need → input → output → verification → validation) that auto-flags traceability gaps, a V&V test matrix with sample-size rationale, a stage-gate/design-review tracker, a DHF index, and a coverage dashboard.
A Design & Development Plan template (Word).
A Design Review Report template (Word).
A start-here guide with license terms.
Design and quality engineers, R&D leads, and startup founders building medical devices or IVDs who need airtight design controls and traceability (ISO 13485 Cl. 7.3 / 21 CFR 820.30) without building the spreadsheets from scratch.
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 Controls System Pack pairs this toolkit with a tailorable Design & Development Control Procedure (SOP) so your design controls are audit-ready, not just organized.
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.