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The procedure and the traceability tools, together. A tailorable Design & Development Control Procedure (SOP) paired with the Design Controls Toolkit — everything you need to run ISO 13485 / 21 CFR 820.30 design controls with airtight traceability.
A tailorable Design & Development Control Procedure (SOP, Word) governing your design process end to end.
The Design Controls Toolkit: a Requirements Traceability Matrix with automatic gap flags, a V&V test matrix, a design-review/stage-gate tracker, a DHF index, and a coverage dashboard.
Design & Development Plan and Design Review Report 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.
Design and quality engineers, R&D leads, and startups building medical devices or IVDs who need the governing procedure and the working tools for design controls and traceability.
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 traceability tools, together. A tailorable Design & Development Control Procedure (SOP) paired with the Design Controls Toolkit — everything you need to run ISO 13485 / 21 CFR 820.30 design controls with airtight traceability.
A tailorable Design & Development Control Procedure (SOP, Word) governing your design process end to end.
The Design Controls Toolkit: a Requirements Traceability Matrix with automatic gap flags, a V&V test matrix, a design-review/stage-gate tracker, a DHF index, and a coverage dashboard.
Design & Development Plan and Design Review Report 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.
Design and quality engineers, R&D leads, and startups building medical devices or IVDs who need the governing procedure and the working tools for design controls and traceability.
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.