Manufacturing Transfers for Medtech Innovators Part 1: Quality Management Considerations When Selecting a Medtech Contract Manufacturing Organization

For medical device manufacturers, the prospect of transferring any part of their company’s operations to an outside vendor is among the most complex and difficult processes they will ever undertake. Whether the transfer involves reliance on an outside product design and development firm, the complete replication of manufacturing and assembly lines at a vendor’s location, or simply hiring a specialized packaging and distribution firm to take on order fulfillment, the manufacturer’s entire business is always at stake. Contract manufacturing organizations (CMOs) that cannot meet the quality requirements of their OEM customers can do permanent harm to the manufacturer’s reputation, regulatory status, and customer contracts—not to mention the potential for increasing risks to patient safety.

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