ISO 13485 Gap Analysis Checklist

The Gap Analysis is one of the most important steps in your project. It helps you determine your path:

• You know where you are.
• The Standard tells you where you need to be
• Anytime they differ you need to change your processes to bridge the gap

We've developed the Gap Analysis Checklist to help you map your path. The Gap Analysis Toolkit will:

• Provide the tools and checklist you need to conduct your Gap Analysis
• Provide a detailed checklist to use to compare your current systems to the requirements of ISO 13485.
• Help you identify the requirements that your organization is already meeting, and those that need to be addressed
• Give you the information you need to determine resources and a timeline for your project.

This Gap Analysis Checklist Toolkit includes:

• A detailed checklist (MS Word) with guidance on what to look for to evaluate your current processes and their compliance to the ISO 13485 Requirements. view screenshot
• Space for notes and observations
• Project Plan
• Project Plan Template

Only $59! That's like getting an electronic GPS for the price of a paper map!

When traveling to unknown areas, a map is a necessity. Likewise, a Gap Analysis will provide you with valuable information to help you plan your Implementation Project. Our Checklist will give you the information you need to bridge the Gap.

$59