Labelling & Medical Device File Pack

Who This Kit Is For

QA/RA professionals and product managers responsible for device labelling, IFUs and technical documentation/medical device files.

The Compliance Problem It Solves

• Inconsistent labelling and IFU content across product lines.
• Technical files or device master records that are incomplete or not clearly structured.
• Challenges showing regulatory bodies a clear, coherent device file with correct labelling evidence.

What You Get In This Kit

• Labelling and IFU structure templates aligned with ISO symbols and MDR/FDA expectations.
• Medical Device File/Technical Documentation templates with clear sectioning.
• Checklists to verify completeness of labelling and device file content.

How This Kit Reduces Your Audit Risk

• Ensures each device has a structured and complete medical device file with associated labelling.
• Improves consistency and regulatory compliance of IFUs and labels.
• Provides clear evidence during technical file reviews and inspections.

How To Implement It (Step-by-Step)

1. Download the templates and adapt to your device range and market jurisdictions.
2. Build or retrofit medical device files using the provided structure.
3. Align labelling and IFUs to the templates and run completeness checks.
4. Maintain and update files as part of change control and PMS updates.

Technical & Regulatory Alignment

• Built for: ISO 13485:2016 device documentation requirements and MDR/FDA technical documentation expectations.
• Typical use: new technical file creation, remediation projects and labelling harmonisation.
• Document type: labelling and device file pack.