On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA ...
The supply chain industry is undergoing a significant transformation, moving away from outdated processes to adopt modern, automated systems that connect all parts of the trading ecosystem. This level ...
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 ...
Change Strategist & Managing Partner at NSP & Co. I'm passionate about sharing change management strategies for our evolving business world. Organizations today are navigating a sea of unprecedented ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback