The importance of accurate compliant medical device labeling has increased significantly in the last few decades.
Compliance requirements are complex and require organizations to have comprehensive management systems and processes in place, which can prove timely, expensive, and labor intensive. Leaving organizations increasingly vulnerable to mislabeling, and non-compliance.
Many organizations remain unsure of the best way to comply with regulatory requirements including what software, processes, and procedures should be implemented to ensure traceability, that records will stand up to enforcement authority scrutiny, and, minimize the risks of errors and product recalls.
The size of the organization does not matter - the FDA and other regulatory bodies do not draw distinctions - so SME organizations must take a strategic approach to the management of their labeling data.
An effective strategy and approach for label management software is vital.
If you would like to find out how compliant your label management software is, we have put together a short health check which will provide feedback to help you identify the FDA requirements for the areas where you should spend more time revising your current labeling strategies.
It takes 2 minutes of your time and, by taking part and leaving your details, you will be entitled to receive a detailed report within the next 2 working days. The report will also give you more information on how our labeling solutions can help with your specific challenges.
Thank you for your time.