ISO 13485 Gap Assessment Starter Pack

Companies starting or repairing an ISO 13485 system usually do not know which clauses are broken, which records are missing, or where to start first. This pack gives you a fast clause-by-clause baseline, a scoring method, and an action-plan structure so you can prioritize remediation before spending money on a full rebuild. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• ISO 13485 Gap Assessment Workbook.xlsx
• Findings and Action Plan Template.docx
• Audit Readiness Checklist.pdf
• Implementation Guide.pdf

Best suited to: Startup manufacturer, Virtual manufacturer, Distributor, and Regulatory consultant.

Useful in audit situations where you need to:

• Show a structured ISO 13485 gap assessment process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to ISO 13485 gap assessment.
• Support EU MDR technical documentation or quality-system reviews where ISO 13485 gap assessment records need to be complete, controlled, and consistent.

Use this pack to tighten execution, strengthen evidence, and make this part of your ISO 13485 system easier to defend under audit.