Context
Cleaning up the Healix Advance and RigidFix IFUs, covering PowerGlide Max and PowerLoc GMDN codes and CE requirements, meant extracting each label's existing content by hand before any of the country versions could be reformatted.
Regulatory Affairs • Device Labeling
Device Label Content Extraction & Country Rollout
Duration: 19 months • Role: Regulatory Affairs Specialist
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.
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- A country-specific IFU/label shipping with content that doesn't match the current master (outdated warning, missing symbol, or wrong classification)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and the destination country's regulatory requirements, tracking every open item (missing translation, missing symbol, outdated claim) through to closure.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 Section Comparison
Master IFU Verification
Outcome
Extracted and reformatted the label content for the required countries, 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.
Have a system like this?
If you have no idea of testing your current system, let's talk through what's actually going on.
Contact me