COTS Risks Every Medical Device Manufacturer Must Overcome

The integration of commercial off the shelf risk(COTS) computers, components, and software in today’s medical devices ensures access to the latest technology, improves patient outcomes, speeds new products to market, and helps control costs. However, COTS systems experience supply-chain disruption, as well as rapid unplanned changes in technology, functionality, and quality. This instability creates real risks to the business, user, and patient.

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