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October 27, 2020


As the EU MDR deadline approaches, seize the opportunity to digitize quality assurance

Susan Gosnell

The postponement of the EU MDR deadlines has given medical device manufacturers a unique opportunity to digitize quality assurance as they take steps to comply with MDR requirements. By seizing this opportunity, MDMs can simplify the compliance process, ensure greater label accuracy and, ultimately, get their products to market faster.

If you’re facing the EU MDR deadline, the last thing you want to contend with is manual quality assurance processes. Imagine having to update hundreds, or thousands, of labels manually, and then approve all of those updates manually. Not only would this represent a tremendous organizational expense in terms of time and resources, it would also open the door for labeling errors. Clearly, digitizing quality assurance is a critical part of an efficient compliance process.

In our work with medical device manufacturers, we help companies digitize the entire label approval workflow and more efficiently manage their label lifecycle, from label and template creation to maintenance and updates.

Digitally approving new templates and labels

Let’s start with label creation. Our label management software, both on-premise and in the Cloud, includes a document management system, which stores all label templates, offers complete version control and ensures secure, role-based access to approved templates. When employees make a change to the template, the system notifies the authorized approver, who can access, review and approve the template within the system.  However, that’s just the beginning. To truly digitize the quality assurance process, you need to be able to approve the finished labels as well. With our variant technology, you can approve every finished label, without having to print a single label. Our label management system retrieves the data from your business system (e.g. ERP or PLM), connects it to the correct, approved template and produces a digital file of the finished label, which you can digitally review and approve. This provides a simple way of approving each finished label before it’s printed.

Digitally approving mass label changes

When you need to update your labels, for example, as a part of EU MDR compliance, our variant technology automates the updating process. Once you’ve made the changes in your ERP or PLM system, you can, with just one click within our label management system, regenerate all of the labels impacted by the change, so you can approve them, again without printing a single one. This functionality helps ensure that all of your labels and templates are up-to-date and accurate, without having to create and print hundreds, or thousands, of individual labels. This approach saves time and valuable resources, and greatly simplifies the compliance process.

Find out more about how our label management system makes life easier for regulated companies.

  • Labeling