IntraOp - Driving Quality Across Supply Chain to Highest Levels
IntraOp - Driving Quality Across Supply Chain to Highest Levels
1 PagesAs an FDA-regulated company, IntraOp must not only design and produce a complex product with electro, mechanical, and software components, but do so while meeting all FDA 21 CFR 820, EU Medical Device Directive (MDD), ISO 13485, Health Canada, and other regulations requirements. So IntraOp needed more than a system to manage all the product details, changes to product, and collaboration efforts with the teams. They also needed a quality management solution to ensure absolute regulatory compliance. IntraOp chose the Arena Solutions platform for both product and quality management. After IntraOp implemented Arena to manage the product and quality processes, the team took the next step to business analytics with Arena Analytics. They wanted Analytics to provide critical day-to-day ins
