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Producing labels and artwork which is accurate, up-to-date, and compliant with country-specific regulations is fraught with risk. As content changes, it needs to be revised, approved, released at the correct time and included in the correct labels/artwork.
As organizations increasingly operate on a global basis, issues such as local language labeling – especially those where languages will have different character sets – accurate translation of IFUs (Instructions For Use), and ensuring both words and images comply with country-specific regulations all pose risks that traditional, silo-based systems may struggle to accommodate.
If these changes are not requested and controlled effectively, the risk that production labels, artwork, PILs (Patient Information Leaflets) or IFUs will contain errors is increased and will result in many recalls and huge cost to the business.
How we helped one of our clients with this challenge:
- New England, USA headquartered Medical Device company
- Significant cost overhead when implementing global label changes, with a minimum of 4 per year
- Centralized system implemented including impact analyses for change control reduced the time to find, and implement label changes
- Estimated cost savings of $350K per global label change equaling $1m+ per year
- Associated reduction in risk of the wrong label being printed at the time of production and faster route to market.
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This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.
REDUCING RISKS LABELING RESOURCES
EU MDR Labeling Compliance: Learn the Lessons from UDI.
The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers.