Leaf Intelligence

Leaf Intelligence

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Leaf Intelligence

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EU IVDR regulation overview
🏛️
Romanian IVDR adoption status
🇮🇹
Italy GTM strategy for IVDs
IVDR Global
SOP & QMS Generation
Standard operating procedures
IVDR Global
EU IVDR compliance guidance
Gap Analysis
Compliance gap identification
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Total SOPs
12% this month
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Approved
8% increase
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Pending Review
3 overdue

Quick Actions

CAPA SOP
Create corrective and preventive action procedures
Complaint Handling
Generate complaint management procedures
Design Controls
Develop design control procedures
Validation
Create validation protocol templates

Recent Documents

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My Documents

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FDA QSR/QMSR
Complete guide to FDA Quality System Regulation including the new QMSR requirements
21 CFR 820 QMSR FDA
ISO 13485:2016
Medical devices quality management systems requirements for regulatory purposes
ISO QMSR International
MDSAP
Medical Device Single Audit Program covering US, Canada, Brazil, Japan, and Australia
MDSAP Global Audit
Warning Letters
Analysis of FDA warning letters and Form 483 observations with prevention strategies
483 Warning Letters Enforcement

Compliance Check

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