Navigating the complex ecosystem of U.S. and global regulators, each with their own requirements for licensing and labeling products, is quite a daunting task. Along with the acquisition of a diverse group of companies, each with their own legacy systems, this global manufacturer of medical devices was struggling to achieve a sustainable, efficient approach to certain regulatory activities.
Enter KPMG. We helped our client implement a three-part digital transformation. A Product Information Management system was developed to track product master data for compliance reporting, while license data is maintained within the global Regulatory Information Management system. And a labeling solution houses electronic Instructions for Use to publish on the company’s website. We helped our client remedy the situation, enabling faster speed to market and reducing compliance risk.
We know how to get things done.