Formulation of Compliance Strategies for Full Product Line Labeling & Packaging
We develop compliance strategies for your full product line labeling and packaging in accordance with regulatory requirements.
Label Content Design, Compilation & Review
We provide label content design, compilation and review services, including designing and writing all content for product labels, instructions for use and outer packaging labels to ensure compliance with MDR, IVDR and ISO standards.
UDI Implementation & Coding Compliance Services
Our UDI implementation and coding compliance services include UDI application, guidance on placement, font size and scannability on labels, packaging and instructions for use, as well as assistance with data entry into the EUDAMED system.
Labeling Change & Compliance Maintenance
We provide post-market product labeling change and compliance maintenance services.
