Description

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Instructions for Use (IFU) Development

User-centered Instructions for Use development meeting FDA, EU MDR/IVDR, and ISO labeling requirements. Clear, compliant documentation ensuring safe and effective device use.

Regulatory Framework

• FDA 21 CFR 801 – Labeling requirements
• EU MDR Annex I – Chapter III labeling
• EU IVDR Annex I – Labeling requirements
• ISO 15223-1 – Symbols for medical devices
• IEC 62366-1 – Usability engineering
• EN 1041 – Information supplied by manufacturer

IFU Components

• Device identification and manufacturer
• Intended use/purpose
• Indications and contraindications
• Warnings and precautions
• Preparation and setup instructions
• Operating procedures
• Maintenance and cleaning
• Troubleshooting
• Technical specifications
• Symbols glossary

IFU Types

• Healthcare professional IFU
• Patient/lay user IFU
• Quick reference guides
• Electronic IFU (eIFU)
• Multi-language IFU masters

Usability Features

• Plain language at appropriate reading level
• Visual instructions and illustrations
• Risk-based warning hierarchy
• ISO symbol integration

Timeline

Standard: 4-8 weeks | Device complexity dependent

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