As medical device and diagnostic manufacturers continue to develop life enhancing products for patients around the world, product labels and instructions for use hold an increasingly important position in providing critical information to healthcare professionals and patients, focused on the safe handling and use of devices. Labeling executives strive to continuously optimize operations, ensuring a streamlined approach to label data collection, real estate formatting and regulatory reviews, and face numerous challenges in achieving each step in-line with regulatory requirements. Risk-based approaches to error minimization in label development and production is at the forefront of labeling team goals, which involves a cross-functional approach to ensure labels and instructions are compliant and intelligible, regardless of the intended user.