ISO 13485 Medical Device Compliance Logbook – Audit-Ready Excel Toolkit for MDR, DHR, CAPA, & Calibration
Medical device manufacturers face stringent ISO 13485:2016 requirements across documentation, CAPA, calibration, and supplier traceability.
Non-compliance risks are not just financial penalties—they can mean loss of certifications, delayed product approvals, and blocked global market entry.
The Prgenix ISO 13485 Compliance Logbook replaces scattered spreadsheets with a structured, audit-ready system trusted by QA managers, regulatory officers, and manufacturers worldwide.
This is not a generic spreadsheet—it’s designed to Big-4 consulting standards:
Structured and branded like professional audit reports
Saves 80+ hours per audit cycle
Comes with audit-ready summaries aligned to ISO 13485 audit requirements
Practical, field-tested, and trusted by QA Managers, Compliance Officers, and ISO-certified manufacturers
Who Should Use This Toolkit?
✅ QA & RA Managers
✅ ISO 13485 Certified Manufacturers
✅ Regulatory Compliance Officers
✅ Audit & Certification Consultants
What’s Inside?
Our compliance toolkits are precision-engineered for audit success, combining real-world regulatory experience with consulting-grade presentation.
✔ Device Master Record (DMR) & Device History Record (DHR) templates
✔ Calibration Tracker with alerts & compliance dashboards
✔ Non-Conformance & CAPA Register to monitor issues and corrective actions
✔ Supplier Qualification Tracker with traceability matrix
✔ Training & Document Control Logs for compliance readiness
✔ Executive Dashboard with risk heatmap, compliance gauges, and NC trends
⚡ Get audit-ready in minutes.
Stop the scramble. Start with the Prgenix ISO 13485 Medical Device Compliance Logbook today.
Frequently Asked Questions
Q: Is this template customizable?
Yes, all fields are editable and adaptable to your processes.
Q: Do I need Excel expertise?
No. It comes pre-built with formulas, charts, and auto-updating dashboards.
Q: Is support included?
Yes, you get email support for setup and usage guidance.
Need Expert Help to File This?
Turn your downloaded toolkit into an audit-ready submission with our professional filing support service.
Our experts handle documentation, verification, and submission — ensuring your filings are accurate, compliant, and regulator-ready. No rework, no penalties, no last-minute rush.
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