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The procedure and the forms it governs, together. A tailorable ISO 14971 Risk Management Procedure (SOP) paired with the full ISO 14971 Template Pack — everything you need to stand up an audit-ready risk management program, not just fill in a form.
A tailorable Risk Management Procedure (SOP, Word) that governs your ISO 14971 process end to end.
The complete ISO 14971 Template Pack: risk assessment workbook (scales, live risk matrix, dFMEA/pFMEA, benefit-risk, file index), plus Risk Management Plan and Report templates.
A “How to Tailor This Procedure” guide that shows exactly what to edit and how the SOP links to the templates.
Single-organization license; edit and co-brand for internal use.
Medical device and IVD teams (especially startups and companies under remediation) who need the governing procedure and the working tools to run ISO 14971 risk management and pass an inspection.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Add to cart and download instantly. Want it done with you instead? See “Work with MEDEVEX.”
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 forms it governs, together. A tailorable ISO 14971 Risk Management Procedure (SOP) paired with the full ISO 14971 Template Pack — everything you need to stand up an audit-ready risk management program, not just fill in a form.
A tailorable Risk Management Procedure (SOP, Word) that governs your ISO 14971 process end to end.
The complete ISO 14971 Template Pack: risk assessment workbook (scales, live risk matrix, dFMEA/pFMEA, benefit-risk, file index), plus Risk Management Plan and Report templates.
A “How to Tailor This Procedure” guide that shows exactly what to edit and how the SOP links to the templates.
Single-organization license; edit and co-brand for internal use.
Medical device and IVD teams (especially startups and companies under remediation) who need the governing procedure and the working tools to run ISO 14971 risk management and pass an inspection.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Add to cart and download instantly. Want it done with you instead? See “Work with MEDEVEX.”
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.