ISO 13485 Medical Device File & Labelling Kit

Build the medical device file clause 4.2.3 requires for each device type or family, in the format your market expects: ISO 13485, US FDA or EU MDR technical documentation, with IFU templates and a submission cross-reference.

What's inside (11 files)

• ISO 13485: Instructions for Use Template; Medical Device File Index; Medical Device File Template.
• US FDA: Device Master Record Register - US FDA; Labeling and IFU Template - US FDA; Medical Device File Template - US FDA.
• EU MDR: IFU Template - EU MDR; Technical Documentation Index - EU MDR; Technical Documentation Template - EU MDR.
• Regulatory Cross-Reference: Regulatory Submission Cross-Reference.

How to use it

1. Choose the template set for your market (ISO 13485 only, US FDA or EU MDR).
2. Create one medical device file per device type or family and complete the index.
3. Link labelling and IFU versions to the file.
4. Use the cross-reference sheet to map the file to your submissions.
5. Keep the file current through design and process changes.

Who it's for

Manufacturers preparing a medical device file or technical documentation for ISO 13485, FDA or EU MDR.

Good to know

• Instant download. Editable Microsoft Office files, no macros.
• Includes a Start Here guide with the contents and how to use them.
• Licensed for one organization, including its sites.
• Templates don't reproduce ISO standards. You need your own licensed copies.
• Advisory notice and field action templates are in the Complaint Handling, PMS & Vigilance Kit.
• Also in the ISO 13485 Complete QMS Kit, which costs less than buying kits separately.