QSR to QMSR Gap-Assessment Tool

This QSR to QMSR Gap Assessment Tool is a cloud based tool designed to make your transition smooth, fast, and audit-ready. Developed by regulatory experts, this tool identifies all gaps between your current QSR-based system and the new QMSR—including ISO 13485 requirements and FDA-specific additions.

How it works:

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Benefits:

• Avoid costly noncompliance
• Save time with a ready-to-use compliance map
• Easy to sort by specific requirements and gaps

What you get:

• A clear, section-by-section gap analysis
• Mapping from QSR to ISO 13485 and QMSR
• Coverage of FDA-specific requirements not in ISO 13485

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