Strict adherence to FDA packaging regulations is crucial for medical device commercial success in the US.
To ensure that medical devices to be sold in the US can be easily identified and traced, the FDA
implemented regulations regarding the labelling of products. Each medical device must be registered
with the FDA on their Global Unique Device Identification Database (GUDID) and have a Unique
Device Identifier (UDI) that is readable by both humans and machines.
Compliance with these regulations requires a labelling system that can print variable data, such as manufacture date and batch information, about each product. The data must be recorded in a GxP‑managed and controlled database for future recall if required.
We responded to this challenge by creating a GxP‑compliant network to manage our computers, servers and Prisym 360 printing system that ensures the integrity of development and manufacturing data is maintained and available upon request. It took us 12 months to validate and commission the system to meet both our own and the FDA’s high standards. Consort Medical now has the capability to supply products to the US market with a system that can be adapted for global use.