FDA marking and traceability requirements can be an intimidating process. Lack of compliance could mean steep penalties, federal prosecution, and more importantly the loss of your company’s reputation. Gravotech has been marking products for over 75 years and has become a global resource in the identification and traceability of products.
This presentation will discuss the requirements of the unique device identification system which adequately identifies medical devices through their distribution and use. Gravotech has developed a complete solution for medical device & instrument marking and tracking. Manufacturers and hospitals have strict marking standards in regards to position, size and contents of the mark leaving no room for error. Additionally, the marks need to be resistant to acid cleaning, corrosion, and high temperature sterilization. With the use of DataMatrixTM codes applied with a Gravotech marking machine, these standards are met with ease.