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Build audit-ready ISO 14971 risk files in a fraction of the time. A senior MedTech consultant’s working toolkit - a live risk workbook plus plan and report templates - the same structure used to build 1,000+ risk documents and support Warning-Letter remediations.
A risk assessment workbook (Excel) with rating scales, a live risk-acceptability matrix, and automatic initial and residual risk scoring.
Design and process FMEA worksheets (RPN = S × O × D).
A benefit-risk summary and a risk-management-file checklist.
A Risk Management Plan template (Word).
A Risk Management Report template (Word).
A start-here guide with license terms.
Medical device and IVD teams, startups through established manufacturers, who need to stand up or clean up ISO 14971 risk management quickly, and quality/regulatory professionals who want a proven structure instead of a blank page.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Need the procedure, not just the templates? The ISO 14971 Risk Management System Pack adds the risk management SOP and tailoring guide that govern these templates.
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.Build audit-ready ISO 14971 risk files in a fraction of the time. A senior MedTech consultant’s working toolkit - a live risk workbook plus plan and report templates - the same structure used to build 1,000+ risk documents and support Warning-Letter remediations.
A risk assessment workbook (Excel) with rating scales, a live risk-acceptability matrix, and automatic initial and residual risk scoring.
Design and process FMEA worksheets (RPN = S × O × D).
A benefit-risk summary and a risk-management-file checklist.
A Risk Management Plan template (Word).
A Risk Management Report template (Word).
A start-here guide with license terms.
Medical device and IVD teams, startups through established manufacturers, who need to stand up or clean up ISO 14971 risk management quickly, and quality/regulatory professionals who want a proven structure instead of a blank page.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Need the procedure, not just the templates? The ISO 14971 Risk Management System Pack adds the risk management SOP and tailoring guide that govern these templates.
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.