Develop an MDR-compliant labeling process

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.

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.

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.

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.

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.