Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...

CEO of Acumatica, a fast-growing cloud ERP company. John has nearly 30 years of industry leadership in cloud services. A growing company often reaches a point of organizational evolution where it ...

Change management software can help your team with everything from learning new features to switching to a new platform to weather organizational restructuring — if you select the right tool, that is.

On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled ...