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Medical design optimization

Are your component providers supplying you with the right testing information?

Device manufacturers are ultimately responsible for the safety and performance of a finished medical device. Therefore, they need to ensure their component suppliers are providing products that meet precise, critical specifications. This article examines the topic of supplier testing and what manufacturers should be demanding from their partners.

Regulatory issues governing the development and sale of medical devices are generally a well understood and necessary aspect of today's global healthcare industry. This ingredient is especially relevant in the United States as applied to long-term implantable medical devices. Historically, government regulatory agencies have relied upon device manufacturers to ensure compliance, as well as to conduct product development and manufacturing activities using accepted industry best practices.

Device manufacturers in turn have relied upon their supply chain of subcomponent providers for components that perform to the standards demanded in the extreme environment known as the human body. But, in many instances, the supply chain is not directly regulated by the same entities that regulate the device manufacturers and, in fact, may be required to answer only for simple performance specifications of their products.

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