Free ISO 13485 Gap Assessment Lite

Many buyers are interested in ISO 13485 but are not ready to buy a full toolkit until they understand the size of their gap. This free lite version gives them a simple first pass and naturally pushes serious users into the paid starter pack. It is positioned as a practical first step that gives buyers immediate value without forcing them into a full rebuild on day one.

What's included

• Mini Clause Checklist.xlsx
• Quick Scorecard.xlsx
• Fast-Start Guide.pdf

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

Download it, put it to work immediately, and use it as the entry point into the full paid system when you need deeper control, stronger records, and a broader implementation framework.