Reducing Risk


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.

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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.




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.

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This solution enables organizations to address the challenges of complying with FDA and other regulations by delivering access to a compliance ready platform in the Cloud.

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Our team of in-house compliance and validation subject matter experts and professional services and support teams can support you from implementation through beyond delivery.

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A Clear Vision whitepaper 1 - A Clear Vision: Developing the Right Strategy to assure Compliant Labeling Inspection A Clear Vision: Developing the Right Strategy to assure Compliant Labeling Inspection Posted in: Whitepaper, Achieving Regulatory Compliance, Increasing The Operational Efficiency, Information Technology, Medical Device, Operations & Labeling, Overcoming The Technical Challenges, Reducing Risks, Regulatory & Compliance -

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.

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