Labeling Services

We can design, create, and route for approval the labels required for your devices to comply with the laws in place at the country of distribution.

Medical device labeling is the essential information provided by manufacturers about a device's purpose, usage, risks, and maintenance. Among others, labeling includes the arwork afixed to the product , instructions for use, user manual, and website. 

This labeling ensures safe and effective use, assisting healthcare professionals and patients while meeting regulatory compliance.

Medical device companies who wish to sell their products in the United States and other countries must adhere to the regulations supplied by the goverment for labeling medical devices. The requirements are different among countries. We can design a label that can be used for global distribution.

In Europe,

• Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (RFID) or bar codes. 
• IFU may be provided electronically in accordance with existing Regulation 207/2012
• Specific requirement to disclose residual risks in form of warnings etc. 
• Any symbol or identification colour used shall conform to the harmonised standards or CS.