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Run (and defend) your quality system. A working QMS-operations workbook plus CAPA and audit templates, built the way MEDEVEX has closed 483s and lifted Warning Letters: gap assessment, CAPA and nonconformance tracking, complaint reportability, and internal audits in one place.
A QMS-operations workbook (Excel): an ISO 13485 / FDA QMSR gap assessment, a CAPA log with overdue flags and days-open, a nonconformance log, a complaint log with MDR reportability tracking, an internal-audit schedule, and a health dashboard.
A CAPA Record template (Word).
An Internal Audit Report template (Word).
A start-here guide with license terms.
Quality managers, RA/QA professionals, and startup founders running a medical device or IVD quality system who need to operate CAPA, nonconformance, complaints, and internal audits (and stay inspection-ready) without building the trackers from scratch.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Want the procedures behind the templates? The QMS Quality Events System Pack adds the CAPA, Non-Conformance, and Complaint-Handling SOPs that govern this toolkit.
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.Run (and defend) your quality system. A working QMS-operations workbook plus CAPA and audit templates, built the way MEDEVEX has closed 483s and lifted Warning Letters: gap assessment, CAPA and nonconformance tracking, complaint reportability, and internal audits in one place.
A QMS-operations workbook (Excel): an ISO 13485 / FDA QMSR gap assessment, a CAPA log with overdue flags and days-open, a nonconformance log, a complaint log with MDR reportability tracking, an internal-audit schedule, and a health dashboard.
A CAPA Record template (Word).
An Internal Audit Report template (Word).
A start-here guide with license terms.
Quality managers, RA/QA professionals, and startup founders running a medical device or IVD quality system who need to operate CAPA, nonconformance, complaints, and internal audits (and stay inspection-ready) without building the trackers from scratch.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Want the procedures behind the templates? The QMS Quality Events System Pack adds the CAPA, Non-Conformance, and Complaint-Handling SOPs that govern this toolkit.
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.