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 ...
ROCHESTER, Mich.--(BUSINESS WIRE)--OneStream Software, a leader in corporate performance management (CPM) solutions for mid-sized to very large enterprises, announced a new OneStream MarketPlace ...
On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA ...
Flexible process control software allows machines from ficonTEC to be more than just the sum of their parts. ficonTEC has always maintained a distinctive modular approach to machine design, with this ...
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