Unique Device Identification (UDI) requirements for medical devices are currently being implemented by Health Authorities like FDA, EU (under new MDR) and MHRA making Unique Device Identifier (UDI) mark mandatory on labels and packages of most medical devices and other global health authorities are expected to adopt similar programs in the coming years. To be UDI compliant, regulatory data management and on-time submission is necessary.
In order to establish compliance you need to follow the following steps:
These processes are essential to successfully receive your UDI and Makrocare would be there with you right from the beginning till the end.
Your regulatory team can manage all the compliance related aspects with our regular assistance. In addition, we provide some other services like:
Our expert team has combineddecades of experience in UDI to offer training and assist your teams. Whether you are beginner or bringing a new product to the market, entering new market or reinforcing compliance on current products in your portfolio, we help you build a plan that ensures timelines are met by speeding up the process, and your resources are not exhausted.
Let's talk about how MakroCare can help you