Context
The EU rollout needed the IFU/label content extracted from existing labels and reformatted against the master content and the destination country's regulatory requirements before translation and submission could begin.
Regulatory Affairs • Labeling
Device Label Content Extraction & Country Rollout
Duration: 7 months • Role: Regulatory Affairs Specialist
Extracting the label information from existing labels for the EU showed that pulling label content by hand is the same task as writing new labels, just backwards. Building a repeatable extraction method paid off across every subsequent country rollout.
Primary Risks Identified
- A country-specific IFU/label shipping with content that doesn't match the current master (outdated warning, missing symbol, or wrong classification)
Testing Approach
Compared each IFU/label section against the master content and the destination country's regulatory requirements, tracking every open item (missing translation, missing symbol, outdated claim) through to closure.
IFU Review
Master Content Comparison
Open Item Tracking
Outcome
Extracted and reformatted the label content for EU, ready for translation/regulatory submission.
Key Lessons
Extracting label content by hand from existing labels is the same task as writing new labels, just backwards - building a repeatable extraction method paid off across every subsequent country rollout.
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