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ISO 13485 and FDA Compliant FDA Gap Analysis Checklist

The Gap Analysis is one of the most important steps in your project. It outlines what areas of your current Quality System need improvement to meet ISO 13485.

This Gap Checklist will help you create an ISO 13485/FDA QSR compliant Quality Management System, regardless of your current system.

• If you have ISO 13485, this checklist highlights the additional requirements you will need to become compliant to the FDA QSR 21CFR-820.
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• If you are starting from scratch, this checklist will also guide you to create an ISO 13485/FDA QSR compliant QMS as it contains both sets of requirements.
• You know where you are (Current Quality Management System).
• You want to be ISO 13485/FDA QSR Compliant
• The difference between these is your gap. Anytime they differ you need to change your processes to bridge the gap.
• The checklist includes a complete ISO 13485/FDA QSR checklist with the FDA requirements highlighted for easy differentiation.

This Gap Analysis Checklist Toolkit includes:

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 ISO 13485/FDA QSR
• 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.
• Highlight the differences between ISO 13485 and FDA QSR.
  

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.

All for only ! That's like getting an electronic GPS for the price of a paper map!