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ISO Cloud Consulting

Labelling & Medical Device File Pack

Labelling & Medical Device File Pack

$399.00 USD
$399.00 USD
Sale Sold out

Teams often reach submissions, audits, or commercial release with weak file structure, inconsistent IFUs, and no reusable template set for notices and device-file control. This pack gives you a cross-jurisdiction labelling and device-file starting point so the commercial and regulatory document set is structured from the beginning. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

  • ISO 13485 IFU Template.docx
  • Advisory Notice Templates.docx
  • Medical Device File Template.docx
  • MDF Index Workbook.xlsx
  • EU MDR IFU Template.docx
  • FDA IFU Template.docx
  • Field Action Notice Template.docx
  • Implementation Guide.pdf

Best suited to: Manufacturer, Distributor, Regulatory consultant, and Quality manager.

Useful in audit situations where you need to:

  • Show a structured labelling and medical device file control process during ISO 13485 certification, surveillance, supplier, or internal audits.
  • Support FDA inspections with controlled records, traceability, and process evidence related to labelling and medical device file control.
  • Support EU MDR technical documentation or quality-system reviews where labelling and medical device file control records need to be complete, controlled, and consistent.

Use this pack to tighten execution, strengthen evidence, and make this part of your ISO 13485 system easier to defend under audit.
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Why Medical Device Companies Use ISO Cloud Consulting Toolkits

Our toolkits are designed by regulatory professionals who work with:

• ISO 13485 certified manufacturers
• medical device startups
• EU MDR compliance projects
• FDA design control programs

Each toolkit contains practical templates used during real audits.

Built for Real Regulatory Audits

These templates are aligned with:

• ISO 13485:2016
• ISO 14971 risk management
• FDA design control expectations
• EU MDR QMS requirements

Auditors evaluate documented evidence, not theory.
These toolkits give you the exact records auditors expect to see.

Start Building Your Audit-Ready QMS Today

Download instantly and begin implementing your system immediately.