Develop an MDR-compliant labeling process
Whether you’re a global company with international reach or a small medical device manufacturer, we can help you create label and packaging artwork processes that help you enable compliance with the latest industry regulations and help you scale your labeling across your enterprise.
Six keys to compliance
Re-think legacy systems
Spreadsheets, legacy systems and even some labeling software packages are not secure. You need an automated, validated solution that can easily accommodate new requirements and safeguard against future regulations.
Centralize your data
Your business may have many locations, but that doesn’t mean it should be “every entity for itself.” Centralized labeling brings visibility and control – and the ability to demonstrate compliance.
Integrate sources of truth
Best practice for managing EU MDR and other labeling regulations is to source data from approved content management systems, trusted ERPs and other applications that generate serial numbers required for EU MDR.
Expedite label changes
Business users should be able to create and manage labels and configure business rules without calling on scarce IT resources. This allows them to quickly respond to any changing regulations.
You need a solution that provides full auditing and reporting capabilities, with business intelligence to monitor and track all medical device labeling activity - as well as eSignature capabilities - to ensure you safely meet regulations.
Enable data-driven labeling
It’s important to have dynamic, data-driven labeling which enables users to manage a single template for a range of labeling variations to support increasing complex requirements and ultimately speed up the validation process.
Keep pace with EU MDR, FDA UDI and 21 CFR Part 11 regulations
Loftware Labeling Solutions helps medical device companies of all sizes manage labeling in a regulated environment by simplifying validation and compliance.
Get the latest developments in labeling in the medical device industry
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