Full control and visibility of content,
design workflows and labeling output
Let us help you
IS YOUR ROLE OPERATION OR LABELING?
Being on the operational side of the business, the onus is on you to ensure all regulations are met. Attention to detail is essential from you and your team, from printed labels and leaflets to data sheets and more.
We provide labeling solutions designed to:
- streamline procedures
- reduce risks by discovering defects in manufacturing
- simplify design approvals
- give a single source of the truth
By using our labeling solution, your legal requirements and regulations will be met; and the number of product recalls, system failures and technical challenges will diminish. Our solutions safeguard against human error, simplifying the process of monitoring compliance.
We guarantee speed and accuracy. All label design and production will be implemented in single process; the business insight that come with our software will give you full control and visibility of content, design workflows and labeling output.
“Since implementing a single solution strategy, we have started to see an improvement in the process – not only do we have the assurance of regulatory compliance but we now have a robust platform to drive operational efficiency and increase productivity. The team has also been good at listening to our feedback – particularly in terms of functionality. The support and ongoing maintenance has made the project very successful.”
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OFFERING THESE PRODUCTS AND SERVICES...
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.
OPERATIONS AND LABELING RESOURCES
EU MDR Labeling Compliance: Learn the Lessons from UDI. Date: 05 December 2017; 3PM GMT / 4PM CET
Whether you’re producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the EU MDR by May 2020.